ABSORB EXTEND Clinical Investigation

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01023789

Collaborator

(none)

812

Enrollment

Locations

Arm

Duration (Months)

14.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease	Device: ABSORB BVS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

812 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABSORB BVS Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease	Device: ABSORB BVS Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Arm

Intervention/Treatment

Experimental: ABSORB BVS

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease

Device: ABSORB BVS

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Outcome Measures

Primary Outcome Measures

Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [≤ 7 days post index procedure (In hospital)]
The composite endpoint composed of Cardiac death, Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [0 to 30 days]
The composite endpoint composed of Cardiac death, Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [0 to 180 days]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [0 to 1 year]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).

Secondary Outcome Measures

Clinical Device Success [On day 0 (immediate post-index procedure)]
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
Clinical Procedure Success [On day 0 (immediate post-index procedure)]
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
Number of Participants With Cardiac Death [≤ 7 days post index procedure (In-hospital )]
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Myocardial Infarction (MI) - Per Protocol [≤ 7 days post index procedure (In-hospital )]
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [≤ 7 days post index procedure (In-hospital )]
Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [≤ 7 days post index procedure (In-hospital )]
Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [≤ 7 days post index procedure (In-hospital )]
Number of Participants With Cardiac Death [0 to 30 days]
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Myocardial Infarction (MI) - Per Protocol [0 to 30 days]
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [0 to 30 days]
Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [0 to 30 days]
Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [0 to 30 days]
Number of Participants With Cardiac Death [0 to 180 days]
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Myocardial Infarction (MI) - Per Protocol [0 to 180 days]
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [0 to 180 days]
Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [0 to 180 days]
Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [0 to 180 days]
Number of Participants With Cardiac Death [0 to 1 year]
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Myocardial Infarction (MI) - Per Protocol [0 to 1 year]
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [0 to 1 year]
Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [0 to 1 year]
Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [0 to 1 year]
Number of Participants With Cardiac Death [0 to 2 year]
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Myocardial Infarction (MI) - Per Protocol [0 to 2 year]
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [0 to 2 year]
Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [0 to 2 year]
Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [0 to 2 year]
Number of Participants With Cardiac Death [0 to 3 years]
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants With Myocardial Infarction (MI) - Per Protocol [0 to 3 years]
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [0 to 3 years]
Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [0 to 3 years]
Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [0 to 3 years]
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [≤ 7 days post index procedure (In hospital)]
The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [0 to 30 days]
The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [0 to 180 days]
The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [0 to 1 year]
The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [0 to 2 years]
The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [0 to 3 years]
The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [0 to 2 years]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [0 to 3 years]
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Scaffold Thrombosis (Early) [0 to 30 days]
According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis [0 to 180 days]
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis (Late) [31 - 365 days]
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis [0 to 1 year]
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis (Very Late) [366 days to 2 years]
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis [0 to 2 years]
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Number of Participants With Scaffold Thrombosis [0 to 3 years]
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Area Stenosis (%) [18 months]
Minimum Lumen Area [18 months]
Mean Vessel Area [18 months]
Minimum Vessel Area [18 months]
Maximum Vessel Area [18 months]
Mean Lumen Area [18 months]
Maximum Lumen Area [18 months]
Mean Plaque Area [18 months]
Minimum Plaque Area [18 months]
Maximum Plaque Area [18 months]
Mean Reference Area [18 months]
Calculated Minimum Lumen Diameter [18 months]
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Calculated Diameter Stenosis [18 months]
The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.

Exclusion Criteria:

Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
Total occlusion (TIMI flow 0), prior to wire passing.
Target vessel(s) contains visible thrombus.
Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
Subject has received brachytherapy in any epicardial vessel (including side branches).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Cardiovascular de Buenos Aires-ICBA	Buenos Aires		Argentina	1428
2	Eastern Heart Clinic, The Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
3	Wesley Hospital	Auchenflower	Queensland	Australia
4	St. Vincent's Hospital	Melbourne	Victoria	Australia	3065
5	Monash Medical Center	Melbourne	Victoria	Australia	3168
6	Allgemeines Krankenhaus Linz	Linz		Austria	4020
7	Onze-Lieve VrouweZiekenhuis	Aalst		Belgium
8	Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia	Sao Paulo		Brazil	04012-180
9	Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein	Sao Paulo		Brazil	05652-901
10	Instituto Coração Triângulo Mineiro	Uberlandia		Brazil	38400-368
11	Montreal Heart Institute	Montreal		Canada	H1T 1C8
12	University of Ottawa Heart Institute	Ottawa		Canada	K1Y 4W7
13	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec		Canada	G1V4G5
14	St. Michael's Hospital	Toronto		Canada	M5B 1W8
15	Prince of Wales Hospital	Hong Kong		China
16	Queen Mary Hospital	Hong Kong		China
17	Århus University Hospital	Århus N		Denmark	8200
18	Institut Jacques Cartier (ICPS)	Massy		France	91300
19	Clinique Pasteur	Toulouse		France	31076
20	Hopital De Rangueil - CHU	Toulouse		France	31403
21	Charité Berlin Campus Steglitz	Berlin		Germany	12203
22	Uni.Klinikum Heidelberg	Heidelberg		Germany	69115
23	Apollo Hospital	Hyderabaad	Andhar Pradesh	India	500033
24	CARE Hospital	Hyderabaad	Andhra Pradesh	India	500034
25	SAL Hospital And Medical Institute	Ahmedabad		India	380054
26	Care Institute of Medical Sciences	Ahmedabad		India	380060
27	Madras Medical Mission	Chennai		India	600 037
28	Medanta -The Medicity	Gurgaon		India	122001
29	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow		India	226014
30	Escorts Heart Institute & Research Centre	New Delhi		India	110 070
31	Rabin Medical Center	Petah Tikva		Israel	49100
32	Catanzaro University Hospital	Catanzaro		Italy	88100
33	Centro Cardiologico Monzino	Milano		Italy
34	Teikyo University	Tokyo	Itabashi	Japan
35	Shonan Kamakura General Hospital	Kamakura	Kanagawa	Japan
36	Saiseikai Yokohama City Eastern Hospital	Yokohama	Kanagawa	Japan
37	Kyoto University Hospital	Kyoto	Kansai	Japan
38	Mitsui Memorial Hospital	Chiyoda-ku		Japan	101-8643
39	Institute Jantung Negara	Kuala Lumpur		Malaysia
40	Catharina ZH Eindhoven	Eindhoven		Netherlands
41	Erasmus Medical Center	Rotterdam		Netherlands
42	Maasstad Ziekenhuis	Rotterdam		Netherlands
43	Mercy Angiography Unit	Auckland		New Zealand	1023
44	Christchurch Hospital	Christchurch		New Zealand
45	University Hospital Krakow	Krakow		Poland	31-501
46	National University Hospital	Singapore		Singapore	119228
47	Sunninghill Hospital	Johannesburg		South Africa
48	Clinico San Carlos	Madrid		Spain
49	La Paz	Madrid		Spain
50	Hospital do Meixoeiro	Pontevedra		Spain	36200
51	Lund University Hospital	Lund		Sweden	221 85
52	Inselspital Bern, Kardiologie	Bern		Switzerland	3010
53	Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
54	National Taiwan University Hospital	Taipei		Taiwan
55	Glenfield Hospital	Leicester		United Kingdom
56	King's College Hospital	London		United Kingdom

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: Alexandre Abizaid, MD, Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Study Chair: Patrick Serruys, MD, Thoraxcenter-Erasmus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01023789

Other Study ID Numbers:

09-386
ACTRN12610000131055
REFCTRI000460, 03-05-2010

First Posted:

Dec 2, 2009

Last Update Posted:

Feb 14, 2018

Last Verified:

Dec 1, 2017

Keywords provided by Abbott Medical Devices

Additional relevant MeSH terms:

Cardiovascular Diseases

Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	A total of 812 subjects (Intent-to-treat population) have been registered in 25 countries across the globe in compliance with the study Clinical Investigation Plan (CIP).
Pre-assignment Detail	Out of the 812 subjects registered, a total of 43 subjects discontinued the study due to death (n=29) , withdrawal of consent (n=1) and lost-to-follow-up or missed the final 3 year follow-up visit (n=13).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Period Title: 30-day Follow-up Visit
STARTED	812
COMPLETED	812
NOT COMPLETED	0
Period Title: 30-day Follow-up Visit
STARTED	812
COMPLETED	812
NOT COMPLETED	0
Period Title: 30-day Follow-up Visit
STARTED	812
COMPLETED	812
NOT COMPLETED	0
Period Title: 30-day Follow-up Visit
STARTED	812
COMPLETED	812
NOT COMPLETED	0
Period Title: 30-day Follow-up Visit
STARTED	812
COMPLETED	769
NOT COMPLETED	43

Baseline Characteristics

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Overall Participants	812
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.12 (10.75)
Sex: Female, Male (Count of Participants)
Female	209 25.7%
Male	603 74.3%
Region of Enrollment (participants) [Number]
Singapore	20 2.5%
Malaysia	23 2.8%
Austria	24 3%
Netherlands	67 8.3%
Sweden	3 0.4%
Hong Kong	21 2.6%
Brazil	97 11.9%
Poland	13 1.6%
France	57 7%
Argentina	20 2.5%
Japan	40 4.9%
United Kingdom	12 1.5%
Switzerland	13 1.6%
India	100 12.3%
Spain	13 1.6%
New Zealand	23 2.8%
Canada	27 3.3%
Belgium	21 2.6%
Taiwan	74 9.1%
Denmark	15 1.8%
Italy	21 2.6%
South Africa	4 0.5%
Israel	13 1.6%
Australia	62 7.6%
Germany	29 3.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Time Frame	≤ 7 days post index procedure (In hospital)

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	14 1.7%

2. Primary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	21 2.6%

3. Primary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	28 3.4%

4. Primary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	41 5%

5. Secondary Outcome

Title	Clinical Device Success
Description	Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
Time Frame	On day 0 (immediate post-index procedure)

Outcome Measure Data

Analysis Population Description
ITT population (Per Lesion analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	809
Measure Target Lesions	871
Number [percentage of lesions]	98.9

6. Secondary Outcome

Title	Clinical Procedure Success
Description	Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
Time Frame	On day 0 (immediate post-index procedure)

Outcome Measure Data

Analysis Population Description
ITT population (Per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	809
Number [percentage of participants]	97.0 11.9%

7. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	0 0%

8. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	14 1.7%

9. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	0 0%

10. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	0 0%

11. Secondary Outcome

Title	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Description
Time Frame	≤ 7 days post index procedure (In-hospital )

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	0 0%

12. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	2 0.2%

13. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	20 2.5%

14. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	4 0.5%

15. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	4 0.5%

16. Secondary Outcome

Title	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Description
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	0 0%

17. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	4 0.5%

18. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	24 3%

19. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	9 1.1%

20. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	11 1.4%

21. Secondary Outcome

Title	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Description
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	4 0.5%

22. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	6 0.7%

23. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	27 3.3%

24. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	19 2.3%

25. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	23 2.8%

26. Secondary Outcome

Title	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Description
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	10 1.2%

27. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame	0 to 2 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	10 1.2%

28. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame	0 to 2 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	35 4.3%

29. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 2 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	34 4.2%

30. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 2 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	46 5.7%

31. Secondary Outcome

Title	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Description
Time Frame	0 to 2 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	20 2.5%

32. Secondary Outcome

Title	Number of Participants With Cardiac Death
Description	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Count of Participants [Participants]	17 2.1%

33. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI) - Per Protocol
Description	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Number [percentage of participants]	39 4.8%

34. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study. Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Count of Participants [Participants]	41 5%

35. Secondary Outcome

Title	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study. Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Count of Participants [Participants]	41 5%

36. Secondary Outcome

Title	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Description
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Count of Participants [Participants]	23 2.8%

37. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	≤ 7 days post index procedure (In hospital)

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	14 1.7%

38. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	21 2.6%

39. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis).

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Count of Participants [Participants]	30 3.7%

40. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Count of Participants [Participants]	45 5.5%

41. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	68 8.4%

42. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Description	The composite endpoint composed of Cardiac death, Myocardial infarction (Q wave and Non-Q wave), Ischemia-driven target vessel revascularization by CABG or PCI.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Count of Participants [Participants]	85 10.5%

43. Secondary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	807
Count of Participants [Participants]	58 7.1%

44. Secondary Outcome

Title	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	801
Count of Participants [Participants]	74 9.1%

45. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis (Early)
Description	According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis)

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	812
Definite	4 0.5%
Probable	1 0.1%
Possible	0 0%

46. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis
Description	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	0 to 180 days

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	811
Definite	6 0.7%
Probable	1 0.1%
Possible	2 0.2%

47. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis (Late)
Description	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	31 - 365 days

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	806
Definite	3 0.4%
Probable	0 0%
Possible	3 0.4%

48. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis
Description	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	0 to 1 year

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	808
Definite	7 0.9%
Probable	1 0.1%
Possible	3 0.4%

49. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis (Very Late)
Description	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	366 days to 2 years

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	794
Definite	4 0.5%
Probable	0 0%
Possible	3 0.4%

50. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis
Description	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	0 to 2 years

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	799
Definite	11 1.4%
Probable	1 0.1%
Possible	6 0.7%

51. Secondary Outcome

Title	Number of Participants With Scaffold Thrombosis
Description	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Time Frame	0 to 3 years

Outcome Measure Data

Analysis Population Description
ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	788
Definite	13 1.6%
Probable	4 0.5%
Possible	11 1.4%

52. Secondary Outcome

Title	Area Stenosis (%)
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [Percentage]	24.71 (20.55)

53. Secondary Outcome

Title	Minimum Lumen Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	3.47 (1.04)

54. Secondary Outcome

Title	Mean Vessel Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	13.77 (3.78)

55. Secondary Outcome

Title	Minimum Vessel Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	9.9 (3.0)

56. Secondary Outcome

Title	Maximum Vessel Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	18.3 (5.3)

57. Secondary Outcome

Title	Mean Lumen Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	4.92 (1.14)

58. Secondary Outcome

Title	Maximum Lumen Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	6.59 (1.53)

59. Secondary Outcome

Title	Mean Plaque Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	8.85 (3.73)

60. Secondary Outcome

Title	Minimum Plaque Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	5.41 (2.59)

61. Secondary Outcome

Title	Maximum Plaque Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	13.18 (5.39)

62. Secondary Outcome

Title	Mean Reference Area
Description
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm^2]	4.78 (1.45)

63. Secondary Outcome

Title	Calculated Minimum Lumen Diameter
Description	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [mm]	2.08 (0.32)

64. Secondary Outcome

Title	Calculated Diameter Stenosis
Description	The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.

Arm/Group Title	ABSORB BVS
Arm/Group Description	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Measure Participants	97
Mean (Standard Deviation) [Percent Diameter stenosis]	14.05 (11.96)

Adverse Events

	ABSORB BVS
Time Frame	3 years
Adverse Event Reporting Description

Arm/Group Title	ABSORB BVS
Arm/Group Description	ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	7/812 (0.9%)
Serious Adverse Events
	ABSORB BVS
	Affected / at Risk (%)	# Events
Total	295/812 (36.3%)
Blood and lymphatic system disorders
ANEMIA	5/812 (0.6%)
HEMORRHAGIC ANEMIA	1/812 (0.1%)
IRON DEFICIENCY ANEMIA	1/812 (0.1%)
NEUTROPHILIA	0/812 (0%)
SPONTANEOUS HEMATOMA	0/812 (0%)
THROMBOCYTOPENIA	0/812 (0%)
Cardiac disorders
ACUTE CORONARY SYNDROME	6/812 (0.7%)
ACUTE MYOCARDIAL INFARCTION	21/812 (2.6%)
ANGINA PECTORIS	80/812 (9.9%)
ANGINA UNSTABLE	12/812 (1.5%)
ARRHYTHMIA	1/812 (0.1%)
ARTERIOSPASM CORONARY	0/812 (0%)
ATRIAL FIBRILLATION	7/812 (0.9%)
ATRIAL FLUTTER	1/812 (0.1%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE	1/812 (0.1%)
BRADYCARDIA	1/812 (0.1%)
CARDIAC ARREST	1/812 (0.1%)
CARDIAC FAILURE	3/812 (0.4%)
CARDIAC FAILURE CHRONIC	1/812 (0.1%)
CARDIAC FAILURE CONGESTIVE	2/812 (0.2%)
CARDIAC TAMPONADE	0/812 (0%)
CARDIOGENIC SHOCK	1/812 (0.1%)
CORONARY ARTERY DISEASE	6/812 (0.7%)
CORONARY ARTERY DISSECTION	9/812 (1.1%)
CORONARY ARTERY OCCLUSION	2/812 (0.2%)
CORONARY ARTERY STENOSIS	4/812 (0.5%)
IN-STENT CORONARY ARTERY RESTENOSIS	2/812 (0.2%)
INTRACARDIAC THROMBUS	0/812 (0%)
MYOCARDIAL INFARCTION	7/812 (0.9%)
MYOCARDIAL ISCHEMIA	3/812 (0.4%)
PALPITATIONS	2/812 (0.2%)
PERICARDIAL EFFUSION	1/812 (0.1%)
PERICARDITIS	1/812 (0.1%)
SICK SINUS SYNDROME	2/812 (0.2%)
SINUS ARREST	0/812 (0%)
STRESS CARDIOMYOPATHY	1/812 (0.1%)
SUPRAVENTRICULAR TACHYCARDIA	0/812 (0%)
TACHYCARDIA	0/812 (0%)
VENTRICULAR EXTRA SYSTOLES	0/812 (0%)
VENTRICULAR FIBRILLATION	0/812 (0%)
VENTRICULAR TACHYCARDIA	2/812 (0.2%)
Congenital, familial and genetic disorders
THYROGLOSSAL CYST	1/812 (0.1%)
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY	0/812 (0%)
TINNITUS	0/812 (0%)
VERTIGO	1/812 (0.1%)
Endocrine disorders
GOITER	1/812 (0.1%)
PRIMARY HYPERALDOSTERONISM	1/812 (0.1%)
Eye disorders
CATARACT	2/812 (0.2%)
CATARACT NUCLEAR	0/812 (0%)
DRY EYE	0/812 (0%)
UVEITIS	1/812 (0.1%)
VISION BLURRED	0/812 (0%)
VITREOUS DEGENERATION	0/812 (0%)
Gastrointestinal disorders
ABDOMINAL DISCOMFORT	1/812 (0.1%)
ABDOMINAL PAIN	3/812 (0.4%)
ABDOMINAL PAIN LOWER	0/812 (0%)
ABDOMINAL PAIN UPPER	0/812 (0%)
ABDOMINAL WALL DISORDER	0/812 (0%)
COLON CANCER	1/812 (0.1%)
COLONIC POLYP	2/812 (0.2%)
CONSTIPATION	2/812 (0.2%)
DIARRHEA	1/812 (0.1%)
DYSPEPSIA	0/812 (0%)
EPIGASTRIC DISCOMFORT	0/812 (0%)
GASTRIC ULCER	1/812 (0.1%)
GASTRIC ULCER HEMORRHAGE	1/812 (0.1%)
GASTRITIS	0/812 (0%)
GASTROINTESTINAL HEMORRHAGE	4/812 (0.5%)
GASTROESOPHAGEAL REFLUX DISEASE	0/812 (0%)
GINGIVAL BLEEDING	0/812 (0%)
GINGIVITIS	0/812 (0%)
GLOSSODYNIA	0/812 (0%)
HAEMATOCHEZIA	1/812 (0.1%)
HAEMORRHOIDS	0/812 (0%)
INGUINAL HERNIA	2/812 (0.2%)
INTESTINAL OBSTRUCTION	1/812 (0.1%)
IRRITABLE BOWEL SYNDROME	0/812 (0%)
MELAENA	1/812 (0.1%)
MOUTH HAEMORRHAGE	0/812 (0%)
NAUSEA	0/812 (0%)
PANCREATITIS	1/812 (0.1%)
PANCREATITIS ACUTE	1/812 (0.1%)
PERITONEAL HAEMORRHAGE	1/812 (0.1%)
SMALL INTESTINAL HAEMORRHAGE	1/812 (0.1%)
TOOTH SOCKET HAEMORRHAGE	0/812 (0%)
UMBILICAL HERNIA	4/812 (0.5%)
VOMITING	0/812 (0%)
General disorders
ADVERSE DRUG REACTION	0/812 (0%)
ASTHENIA	1/812 (0.1%)
CATHETER SITE HAEMATOMA	0/812 (0%)
CATHETER SITE HAEMORRHAGE	0/812 (0%)
CATHETER SITE PAIN	0/812 (0%)
CATHETER SITE RELATED REACTION	0/812 (0%)
CATHETER SITE SWELLING	0/812 (0%)
CHEST DISCOMFORT	4/812 (0.5%)
CHEST PAIN	5/812 (0.6%)
CHILLS	0/812 (0%)
DEATH	4/812 (0.5%)
DEVICE DISLOCATION	0/812 (0%)
DEVICE MALFUNCTION	2/812 (0.2%)
DEVICE OCCLUSION	1/812 (0.1%)
DROWNING	1/812 (0.1%)
FATIGUE	0/812 (0%)
GENERAL SYMPTOM	0/812 (0%)
MALAISE	0/812 (0%)
MASS	0/812 (0%)
NON-CARDIAC CHEST PAIN	20/812 (2.5%)
OEDEMA	0/812 (0%)
OEDEMA PERIPHERAL	0/812 (0%)
PAIN	0/812 (0%)
PYREXIA	3/812 (0.4%)
SUDDEN CARDIAC DEATH	2/812 (0.2%)
SUDDEN DEATH	1/812 (0.1%)
THROMBOSIS IN DEVICE	6/812 (0.7%)
VESSEL PUNCTURE SITE HAEMORRHAGE	0/812 (0%)
Hepatobiliary disorders
CHOLECYSTITIS	2/812 (0.2%)
CHOLECYSTITIS ACUTE	1/812 (0.1%)
CHOLECYSTITIS CHRONIC	1/812 (0.1%)
CHOLELITHIASIS	4/812 (0.5%)
HEPATIC STEATOSIS	0/812 (0%)
HYPERBILIRUBINAEMIA	0/812 (0%)
LIVER DISORDER	0/812 (0%)
NON-ALCOHOLIC STEATOHEPATITIS	0/812 (0%)
Immune system disorders
ALLERGY TO ARTHROPOD STING	1/812 (0.1%)
CONTRAST MEDIA ALLERGY	1/812 (0.1%)
DRUG HYPERSENSITIVITY	0/812 (0%)
HYPERSENSITIVITY	0/812 (0%)
Infections and infestations
ABSCESS LIMB	1/812 (0.1%)
BACTERIAL SEPSIS	1/812 (0.1%)
BRONCHITIS	0/812 (0%)
CAMPYLOBACTER GASTROENTERITIS	0/812 (0%)
DIVERTICULITIS	1/812 (0.1%)
EMPYEMA	0/812 (0%)
GASTROENTERITIS	3/812 (0.4%)
GASTROINTESTINAL INFECTION	0/812 (0%)
GROIN ABSCESS	0/812 (0%)
HERPES SIMPLEX	0/812 (0%)
HERPES ZOSTER	0/812 (0%)
INFECTED BITES	0/812 (0%)
INFLUENZA	0/812 (0%)
KIDNEY INFECTION	0/812 (0%)
LIVER ABSCESS	1/812 (0.1%)
LOWER RESPIRATORY TRACT INFECTION	1/812 (0.1%)
LUNG INFECTION	3/812 (0.4%)
LYMPHANGITIS	1/812 (0.1%)
NASOPHARYNGITIS	0/812 (0%)
NOSOCOMIAL INFECTION	0/812 (0%)
OSTEOMYELITIS	1/812 (0.1%)
OSTEOMYELITIS ACUTE	1/812 (0.1%)
PNEUMONIA	6/812 (0.7%)
PNEUMONIA PNEUMOCOCCAL	1/812 (0.1%)
PNEUMONIA PRIMARY ATYPICAL	1/812 (0.1%)
POSTOPERATIVE WOUND INFECTION	1/812 (0.1%)
RASH PUSTULAR	0/812 (0%)
RESPIRATORY TRACT INFECTION	2/812 (0.2%)
SEPSIS	1/812 (0.1%)
SEPTIC SHOCK	1/812 (0.1%)
TOOTH INFECTION	0/812 (0%)
TUBERCULOSIS	0/812 (0%)
UPPER RESPIRATORY TRACT INFECTION	0/812 (0%)
URINARY TRACT INFECTION	3/812 (0.4%)
VARICELLA	0/812 (0%)
VIRAL INFECTION	0/812 (0%)
WOUND INFECTION	1/812 (0.1%)
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE	0/812 (0%)
ANKLE FRACTURE	0/812 (0%)
BACK INJURY	1/812 (0.1%)
CARDIAC PROCEDURE COMPLICATION	1/812 (0.1%)
CATHETER SITE HAEMATOMA	0/812 (0%)
CLAVICLE FRACTURE	0/812 (0%)
CONTUSION	0/812 (0%)
CORONARY ARTERY RESTENOSIS	2/812 (0.2%)
ENDOTRACHEAL INTUBATION COMPLICATION	0/812 (0%)
FALL	0/812 (0%)
FEMORAL NECK FRACTURE	1/812 (0.1%)
FEMUR FRACTURE	1/812 (0.1%)
FOREIGN BODY	1/812 (0.1%)
IN-STENT ARTERIAL RESTENOSIS	1/812 (0.1%)
IN-STENT CORONARY ARTERY RESTENOSIS	7/812 (0.9%)
INJURY	0/812 (0%)
JOINT INJURY	0/812 (0%)
LACERATION	1/812 (0.1%)
LIMB CRUSHING INJURY	1/812 (0.1%)
LIMB INJURY	0/812 (0%)
OVERDOSE	0/812 (0%)
PELVIC FRACTURE	1/812 (0.1%)
PERIORBITAL HAEMATOMA	0/812 (0%)
PLAQUE SHIFT	0/812 (0%)
POST PROCEDURAL HAEMORRHAGE	1/812 (0.1%)
POST PROCEDURAL MYOCARDIAL INFARCTION	10/812 (1.2%)
POST PROCEDURAL SWELLING	1/812 (0.1%)
PROCEDURAL HEADACHE	0/812 (0%)
PROCEDURAL HYPERTENSION	0/812 (0%)
PROCEDURAL HYPOTENSION	1/812 (0.1%)
PROCEDURAL NAUSEA	0/812 (0%)
RADIATION OESOPHAGITIS	1/812 (0.1%)
SPINAL COMPRESSION FRACTURE	1/812 (0.1%)
TENDON INJURY	1/812 (0.1%)
URINARY RETENTION POSTOPERATIVE	1/812 (0.1%)
VASCULAR PSEUDOANEURYSM	3/812 (0.4%)
WOUND DEHISCENCE	0/812 (0%)
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED	0/812 (0%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED	0/812 (0%)
BLOOD CREATININE INCREASED	0/812 (0%)
BLOOD GLUCOSE INCREASED	0/812 (0%)
BLOOD PRESSURE ABNORMAL	0/812 (0%)
BLOOD PRESSURE DECREASED	0/812 (0%)
BLOOD PRESSURE INCREASED	0/812 (0%)
BLOOD PRESSURE SYSTOLIC INCREASED	0/812 (0%)
C-REACTIVE PROTEIN INCREASED	0/812 (0%)
CARCINOEMBRYONIC ANTIGEN INCREASED	1/812 (0.1%)
CARDIAC ENZYMES INCREASED	2/812 (0.2%)
CARDIAC STRESS TEST ABNORMAL	3/812 (0.4%)
ELECTROCARDIOGRAM ST SEGMENT ELEVATION	0/812 (0%)
FEMORAL BRUIT	0/812 (0%)
GLYCOSYLATED HAEMOGLOBIN INCREASED	0/812 (0%)
HEART RATE INCREASED	0/812 (0%)
HEPATIC ENZYME INCREASED	0/812 (0%)
INTERNATIONAL NORMALISED RATIO INCREASED	0/812 (0%)
LIVER FUNCTION TEST ABNORMAL	0/812 (0%)
LOW DENSITY LIPOPROTEIN INCREASED	0/812 (0%)
OXYGEN SATURATION DECREASED	0/812 (0%)
RED BLOOD CELL SEDIMENTATION RATE INCREASED	0/812 (0%)
TROPONIN I INCREASED	0/812 (0%)
TROPONIN INCREASED	0/812 (0%)
TROPONIN T INCREASED	1/812 (0.1%)
Metabolism and nutrition disorders
DIABETES MELLITUS	2/812 (0.2%)
DYSLIPIDAEMIA	0/812 (0%)
FLUID RETENTION	0/812 (0%)
GLUCOSE TOLERANCE IMPAIRED	0/812 (0%)
GOUT	0/812 (0%)
HYPERGLYCAEMIA	0/812 (0%)
HYPERKALAEMIA	0/812 (0%)
HYPONATRAEMIA	0/812 (0%)
IRON DEFICIENCY	0/812 (0%)
TYPE 2 DIABETES MELLITUS	0/812 (0%)
VITAMIN D DEFICIENCY	0/812 (0%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/812 (0%)
ARTHRITIS	0/812 (0%)
BACK PAIN	1/812 (0.1%)
BURSITIS	0/812 (0%)
COSTOCHONDRITIS	0/812 (0%)
INTERVERTEBRAL DISC DEGENERATION	0/812 (0%)
INTERVERTEBRAL DISC PROTRUSION	1/812 (0.1%)
JAW CYST	1/812 (0.1%)
JOINT SWELLING	0/812 (0%)
MUSCLE SPASMS	0/812 (0%)
MUSCULAR WEAKNESS	0/812 (0%)
MUSCULOSKELETAL CHEST PAIN	1/812 (0.1%)
MUSCULOSKELETAL DISCOMFORT	1/812 (0.1%)
MUSCULOSKELETAL PAIN	0/812 (0%)
MUSCULOSKELETAL STIFFNESS	0/812 (0%)
MYALGIA	0/812 (0%)
NECK PAIN	0/812 (0%)
OSTEOARTHRITIS	5/812 (0.6%)
PAIN IN EXTREMITY	2/812 (0.2%)
POLYARTHRITIS	1/812 (0.1%)
SPINAL COLUMN STENOSIS	1/812 (0.1%)
SPINAL OSTEOARTHRITIS	0/812 (0%)
SPONDYLITIS	1/812 (0.1%)
TENDONITIS	0/812 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA	0/812 (0%)
BONE NEOPLASM	1/812 (0.1%)
BREAST CANCER	1/812 (0.1%)
COLON CANCER	3/812 (0.4%)
HAIR FOLLICLE TUMOUR BENIGN	0/812 (0%)
HEPATIC NEOPLASM MALIGNANT	1/812 (0.1%)
HODGKIN'S DISEASE	1/812 (0.1%)
LARYNGEAL CANCER	1/812 (0.1%)
LUNG NEOPLASM	0/812 (0%)
LUNG NEOPLASM MALIGNANT	4/812 (0.5%)
MALIGNANT MELANOMA	1/812 (0.1%)
MEDIASTINUM NEOPLASM	1/812 (0.1%)
MESOTHELIOMA	1/812 (0.1%)
METASTASES TO CENTRAL NERVOUS SYSTEM	1/812 (0.1%)
MULTIPLE MYELOMA	1/812 (0.1%)
NEOPLASM MALIGNANT	1/812 (0.1%)
PROSTATE CANCER	2/812 (0.2%)
RENAL CANCER	1/812 (0.1%)
RETROPERITONEAL NEOPLASM	1/812 (0.1%)
SKIN CANCER	0/812 (0%)
SOFT TISSUE NEOPLASM	0/812 (0%)
VULVAL CANCER	1/812 (0.1%)
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS	1/812 (0.1%)
BALANCE DISORDER	0/812 (0%)
BURNING SENSATION	0/812 (0%)
CAROTID ARTERY STENOSIS	4/812 (0.5%)
CARPAL TUNNEL SYNDROME	0/812 (0%)
CEREBRAL HAEMATOMA	1/812 (0.1%)
CEREBRAL INFARCTION	2/812 (0.2%)
CEREBROVASCULAR ACCIDENT	5/812 (0.6%)
DEMENTIA	0/812 (0%)
DIZZINESS	1/812 (0.1%)
DIZZINESS POSTURAL	0/812 (0%)
ENCEPHALITIS	1/812 (0.1%)
EXERTIONAL HEADACHE	0/812 (0%)
HEADACHE	0/812 (0%)
HYPOAESTHESIA	0/812 (0%)
ISCHAEMIC STROKE	1/812 (0.1%)
LETHARGY	0/812 (0%)
LOSS OF CONSCIOUSNESS	1/812 (0.1%)
LUMBAR RADICULOPATHY	1/812 (0.1%)
MIGRAINE	0/812 (0%)
PARAESTHESIA	0/812 (0%)
PARKINSON'S DISEASE	0/812 (0%)
PARKINSONISM	1/812 (0.1%)
PRESYNCOPE	3/812 (0.4%)
SYNCOPE	4/812 (0.5%)
TRANSIENT ISCHAEMIC ATTACK	5/812 (0.6%)
TREMOR	0/812 (0%)
Psychiatric disorders
ABNORMAL BEHAVIOUR	1/812 (0.1%)
ANXIETY	0/812 (0%)
CONFUSIONAL STATE	0/812 (0%)
DELIRIUM	0/812 (0%)
DEPRESSION	2/812 (0.2%)
INSOMNIA	0/812 (0%)
MAJOR DEPRESSION	1/812 (0.1%)
MANIA	1/812 (0.1%)
MENTAL DISORDER	1/812 (0.1%)
MOOD SWINGS	0/812 (0%)
NERVOUSNESS	0/812 (0%)
PANIC ATTACK	0/812 (0%)
RESTLESSNESS	0/812 (0%)
SUICIDE ATTEMPT	1/812 (0.1%)
Renal and urinary disorders
BLADDER DILATATION	0/812 (0%)
BLADDER OBSTRUCTION	1/812 (0.1%)
CALCULUS URINARY	1/812 (0.1%)
DYSURIA	0/812 (0%)
POLLAKIURIA	0/812 (0%)
RENAL ARTERY STENOSIS	2/812 (0.2%)
RENAL COLIC	2/812 (0.2%)
RENAL FAILURE	0/812 (0%)
RENAL FAILURE ACUTE	2/812 (0.2%)
RENAL IMPAIRMENT	0/812 (0%)
RENAL MASS	1/812 (0.1%)
URETHRAL STENOSIS	0/812 (0%)
URINARY TRACT OBSTRUCTION	1/812 (0.1%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA	0/812 (0%)
BREAST CALCIFICATIONS	0/812 (0%)
GYNAECOMASTIA	0/812 (0%)
MENORRHAGIA	0/812 (0%)
UTERINE POLYP	0/812 (0%)
VAGINAL HAEMORRHAGE	1/812 (0.1%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA	2/812 (0.2%)
ACUTE RESPIRATORY FAILURE	2/812 (0.2%)
ASTHMA	1/812 (0.1%)
BRONCHITIS CHRONIC	0/812 (0%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	3/812 (0.4%)
COUGH	0/812 (0%)
DYSPNOEA	7/812 (0.9%)
DYSPNOEA EXERTIONAL	3/812 (0.4%)
EPISTAXIS	0/812 (0%)
HAEMOPTYSIS	1/812 (0.1%)
HAEMOTHORAX	1/812 (0.1%)
LUNG DISORDER	0/812 (0%)
NOCTURNAL DYSPNOEA	0/812 (0%)
PLEURAL EFFUSION	1/812 (0.1%)
PLEURISY	0/812 (0%)
PNEUMONIA ASPIRATION	1/812 (0.1%)
PRODUCTIVE COUGH	0/812 (0%)
PULMONARY EMBOLISM	2/812 (0.2%)
PULMONARY OEDEMA	1/812 (0.1%)
RALES	0/812 (0%)
RESPIRATORY DISTRESS	1/812 (0.1%)
RESPIRATORY FAILURE	1/812 (0.1%)
SLEEP APNOEA SYNDROME	2/812 (0.2%)
Skin and subcutaneous tissue disorders
DRUG ERUPTION	0/812 (0%)
ECCHYMOSIS	0/812 (0%)
ECZEMA	0/812 (0%)
IDIOPATHIC URTICARIA	0/812 (0%)
INCREASED TENDENCY TO BRUISE	0/812 (0%)
NIGHT SWEATS	0/812 (0%)
PRURITUS	0/812 (0%)
PRURITUS GENERALISED	0/812 (0%)
PSORIASIS	0/812 (0%)
RASH	0/812 (0%)
RASH GENERALISED	0/812 (0%)
RASH PRURITIC	0/812 (0%)
SKIN DISCOLOURATION	0/812 (0%)
SKIN LESION	0/812 (0%)
SKIN ULCER	0/812 (0%)
URTICARIA	0/812 (0%)
Social circumstances
OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS	0/812 (0%)
Surgical and medical procedures
CARDIAC ABLATION	1/812 (0.1%)
CARDIAC PACEMAKER INSERTION	1/812 (0.1%)
CHOLECYSTECTOMY	1/812 (0.1%)
FLUID REPLACEMENT	1/812 (0.1%)
PERIPHERAL ARTERY ANGIOPLASTY	1/812 (0.1%)
PROSTATECTOMY	1/812 (0.1%)
TOOTH EXTRACTION	0/812 (0%)
URETHRAL STENT REMOVAL	1/812 (0.1%)
VASECTOMY	0/812 (0%)
Vascular disorders
AORTIC ANEURYSM	1/812 (0.1%)
BLOOD PRESSURE INADEQUATELY CONTROLLED	0/812 (0%)
HAEMATOMA	0/812 (0%)
HAEMORRHAGE	0/812 (0%)
HYPERTENSION	0/812 (0%)
HYPERTENSIVE CRISIS	0/812 (0%)
HYPERTENSIVE EMERGENCY	1/812 (0.1%)
HYPOTENSION	2/812 (0.2%)
ILIAC ARTERY OCCLUSION	1/812 (0.1%)
INTERMITTENT CLAUDICATION	0/812 (0%)
ORTHOSTATIC HYPOTENSION	1/812 (0.1%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	2/812 (0.2%)
PERIPHERAL COLDNESS	0/812 (0%)
PERIPHERAL ISCHAEMIA	1/812 (0.1%)
PERIPHERAL VASCULAR DISORDER	2/812 (0.2%)
SUBCLAVIAN ARTERY STENOSIS	1/812 (0.1%)
VENOUS INSUFFICIENCY	1/812 (0.1%)
VENOUS THROMBOSIS	0/812 (0%)
Other (Not Including Serious) Adverse Events
	ABSORB BVS
	Affected / at Risk (%)	# Events
Total	808/812 (99.5%)
Blood and lymphatic system disorders
ANEMIA	4/812 (0.5%)
HEMORRHAGIC ANEMIA	0/812 (0%)
IRON DEFICIENCY ANEMIA	0/812 (0%)
NEUTROPHILIA	1/812 (0.1%)
SPONTANEOUS HEMATOMA	1/812 (0.1%)
THROMBOCYTOPENIA	1/812 (0.1%)
Cardiac disorders
ACUTE CORONARY SYNDROME	0/812 (0%)
ACUTE MYOCARDIAL INFARCTION	1/812 (0.1%)
ANGINA PECTORIS	66/812 (8.1%)
ANGINA UNSTABLE	4/812 (0.5%)
ARRHYTHMIA	3/812 (0.4%)
ARTERIOSPASM CORONARY	1/812 (0.1%)
ATRIAL FIBRILLATION	9/812 (1.1%)
ATRIAL FLUTTER	2/812 (0.2%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE	0/812 (0%)
BRADYCARDIA	5/812 (0.6%)
CARDIAC ARREST	0/812 (0%)
CARDIAC FAILURE	2/812 (0.2%)
CARDIAC FAILURE CHRONIC	0/812 (0%)
CARDIAC FAILURE CONGESTIVE	1/812 (0.1%)
CARDIAC TAMPONADE	1/812 (0.1%)
CARDIOGENIC SHOCK	0/812 (0%)
CORONARY ARTERY DISEASE	0/812 (0%)
CORONARY ARTERY DISSECTION	16/812 (2%)
CORONARY ARTERY OCCLUSION	1/812 (0.1%)
CORONARY ARTERY STENOSIS	0/812 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS	0/812 (0%)
INTRACARDIAC THROMBUS	1/812 (0.1%)
MYOCARDIAL INFARCTION	0/812 (0%)
MYOCARDIAL ISCHEMIA	0/812 (0%)
PALPITATIONS	8/812 (1%)
PERICARDIAL EFFUSION	1/812 (0.1%)
PERICARDITIS	0/812 (0%)
SICK SINUS SYNDROME	0/812 (0%)
SINUS ARREST	1/812 (0.1%)
STRESS CARDIOMYOPATHY	0/812 (0%)
SUPRAVENTRICULAR TACHYCARDIA	1/812 (0.1%)
TACHYCARDIA	2/812 (0.2%)
VENTRICULAR EXTRA SYSTOLES	3/812 (0.4%)
VENTRICULAR FIBRILLATION	1/812 (0.1%)
VENTRICULAR TACHYCARDIA	1/812 (0.1%)
Congenital, familial and genetic disorders
THYROGLOSSAL CYST	0/812 (0%)
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY	1/812 (0.1%)
TINNITUS	1/812 (0.1%)
VERTIGO	2/812 (0.2%)
Endocrine disorders
GOITER	1/812 (0.1%)
PRIMARY HYPERALDOSTERONISM	0/812 (0%)
Eye disorders
CATARACT	1/812 (0.1%)
CATARACT NUCLEAR	1/812 (0.1%)
DRY EYE	2/812 (0.2%)
UVEITIS	0/812 (0%)
VISION BLURRED	1/812 (0.1%)
VITREOUS DEGENERATION	1/812 (0.1%)
Gastrointestinal disorders
ABDOMINAL DISCOMFORT	1/812 (0.1%)
ABDOMINAL PAIN	4/812 (0.5%)
ABDOMINAL PAIN LOWER	1/812 (0.1%)
ABDOMINAL PAIN UPPER	6/812 (0.7%)
ABDOMINAL WALL DISORDER	1/812 (0.1%)
COLON CANCER	0/812 (0%)
COLONIC POLYP	1/812 (0.1%)
CONSTIPATION	3/812 (0.4%)
DIARRHEA	11/812 (1.4%)
DYSPEPSIA	5/812 (0.6%)
EPIGASTRIC DISCOMFORT	1/812 (0.1%)
GASTRIC ULCER	0/812 (0%)
GASTRIC ULCER HEMORRHAGE	0/812 (0%)
GASTRITIS	5/812 (0.6%)
GASTROINTESTINAL HEMORRHAGE	0/812 (0%)
GASTROESOPHAGEAL REFLUX DISEASE	1/812 (0.1%)
GINGIVAL BLEEDING	1/812 (0.1%)
GINGIVITIS	1/812 (0.1%)
GLOSSODYNIA	1/812 (0.1%)
HEMATOCHEZIA	0/812 (0%)
HEMORRHOIDS	4/812 (0.5%)
INGUINAL HERNIA	0/812 (0%)
INTESTINAL OBSTRUCTION	0/812 (0%)
IRRITABLE BOWEL SYNDROME	2/812 (0.2%)
MELENA	0/812 (0%)
MOUTH HEMORRHAGE	1/812 (0.1%)
NAUSEA	6/812 (0.7%)
PANCREATITIS	0/812 (0%)
PANCREATITIS ACUTE	0/812 (0%)
PERITONEAL HEMORRHAGE	0/812 (0%)
SMALL INTESTINAL HEMORRHAGE	0/812 (0%)
TOOTH SOCKET HEMORRHAGE	1/812 (0.1%)
UMBILICAL HERNIA	0/812 (0%)
VOMITING	1/812 (0.1%)
General disorders
ADVERSE DRUG REACTION	27/812 (3.3%)
ASTHENIA	6/812 (0.7%)
CATHETER SITE HAEMATOMA	40/812 (4.9%)
CATHETER SITE HAEMORRHAGE	17/812 (2.1%)
CATHETER SITE PAIN	12/812 (1.5%)
CATHETER SITE RELATED REACTION	2/812 (0.2%)
CATHETER SITE SWELLING	1/812 (0.1%)
CHEST DISCOMFORT	13/812 (1.6%)
CHEST PAIN	7/812 (0.9%)
CHILLS	1/812 (0.1%)
DEVICE DISLOCATION	2/812 (0.2%)
DEVICE MALFUNCTION	0/812 (0%)
DEVICE OCCLUSION	0/812 (0%)
DROWNING	0/812 (0%)
FATIGUE	16/812 (2%)
GENERAL SYMPTOM	1/812 (0.1%)
MALAISE	1/812 (0.1%)
MASS	1/812 (0.1%)
NON-CARDIAC CHEST PAIN	63/812 (7.8%)
OEDEMA	1/812 (0.1%)
OEDEMA PERIPHERAL	7/812 (0.9%)
PAIN	1/812 (0.1%)
PYREXIA	6/812 (0.7%)
THROMBOSIS IN DEVICE	0/812 (0%)
VESSEL PUNCTURE SITE HAEMORRHAGE	1/812 (0.1%)
Hepatobiliary disorders
CHOLECYSTITIS	0/812 (0%)
CHOLECYSTITIS ACUTE	0/812 (0%)
CHOLECYSTITIS CHRONIC	0/812 (0%)
CHOLELITHIASIS	0/812 (0%)
HEPATIC STEATOSIS	1/812 (0.1%)
HYPERBILIRUBINAEMIA	1/812 (0.1%)
LIVER DISORDER	1/812 (0.1%)
NON-ALCOHOLIC STEATOHEPATITIS	1/812 (0.1%)
Immune system disorders
ALLERGY TO ARTHROPOD STING	0/812 (0%)
CONTRAST MEDIA ALLERGY	1/812 (0.1%)
DRUG HYPERSENSITIVITY	4/812 (0.5%)
HYPERSENSITIVITY	4/812 (0.5%)
Infections and infestations
ABSCESS LIMB	0/812 (0%)
BACTERIAL SEPSIS	0/812 (0%)
BRONCHITIS	3/812 (0.4%)
CAMPYLOBACTER GASTROENTERITIS	1/812 (0.1%)
DIVERTICULITIS	0/812 (0%)
EMPYEMA	1/812 (0.1%)
GASTROENTERITIS	2/812 (0.2%)
GASTROINTESTINAL INFECTION	2/812 (0.2%)
GROIN ABSCESS	1/812 (0.1%)
HERPES SIMPLEX	1/812 (0.1%)
HERPES ZOSTER	3/812 (0.4%)
INFECTED BITES	1/812 (0.1%)
INFLUENZA	2/812 (0.2%)
KIDNEY INFECTION	1/812 (0.1%)
LIVER ABSCESS	0/812 (0%)
LOWER RESPIRATORY TRACT INFECTION	2/812 (0.2%)
LUNG INFECTION	1/812 (0.1%)
LYMPHANGITIS	0/812 (0%)
NASOPHARYNGITIS	4/812 (0.5%)
NOSOCOMIAL INFECTION	1/812 (0.1%)
OSTEOMYELITIS	0/812 (0%)
OSTEOMYELITIS ACUTE	0/812 (0%)
PNEUMONIA	3/812 (0.4%)
PNEUMONIA PNEUMOCOCCAL	0/812 (0%)
PNEUMONIA PRIMARY ATYPICAL	0/812 (0%)
POSTOPERATIVE WOUND INFECTION	0/812 (0%)
RASH PUSTULAR	1/812 (0.1%)
RESPIRATORY TRACT INFECTION	1/812 (0.1%)
SEPSIS	0/812 (0%)
SEPTIC SHOCK	0/812 (0%)
TOOTH INFECTION	1/812 (0.1%)
TUBERCULOSIS	1/812 (0.1%)
UPPER RESPIRATORY TRACT INFECTION	2/812 (0.2%)
URINARY TRACT INFECTION	4/812 (0.5%)
VARICELLA	1/812 (0.1%)
VIRAL INFECTION	1/812 (0.1%)
WOUND INFECTION	1/812 (0.1%)
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE	1/812 (0.1%)
ANKLE FRACTURE	1/812 (0.1%)
BACK INJURY	0/812 (0%)
CARDIAC PROCEDURE COMPLICATION	0/812 (0%)
CATHETER SITE HAEMATOMA	3/812 (0.4%)
CLAVICLE FRACTURE	1/812 (0.1%)
CONTUSION	1/812 (0.1%)
CORONARY ARTERY RESTENOSIS	0/812 (0%)
ENDOTRACHEAL INTUBATION COMPLICATION	1/812 (0.1%)
FALL	3/812 (0.4%)
FEMORAL NECK FRACTURE	0/812 (0%)
FEMUR FRACTURE	0/812 (0%)
FOREIGN BODY	0/812 (0%)
IN-STENT ARTERIAL RESTENOSIS	0/812 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS	3/812 (0.4%)
INJURY	1/812 (0.1%)
JOINT INJURY	2/812 (0.2%)
LACERATION	2/812 (0.2%)
LIMB CRUSHING INJURY	0/812 (0%)
LIMB INJURY	1/812 (0.1%)
OVERDOSE	1/812 (0.1%)
PELVIC FRACTURE	0/812 (0%)
PERIORBITAL HAEMATOMA	1/812 (0.1%)
PLAQUE SHIFT	1/812 (0.1%)
POST PROCEDURAL HAEMORRHAGE	0/812 (0%)
POST PROCEDURAL MYOCARDIAL INFARCTION	13/812 (1.6%)
POST PROCEDURAL SWELLING	0/812 (0%)
PROCEDURAL HEADACHE	2/812 (0.2%)
PROCEDURAL HYPERTENSION	4/812 (0.5%)
PROCEDURAL HYPOTENSION	4/812 (0.5%)
PROCEDURAL NAUSEA	7/812 (0.9%)
RADIATION OESOPHAGITIS	0/812 (0%)
SPINAL COMPRESSION FRACTURE	0/812 (0%)
TENDON INJURY	0/812 (0%)
URINARY RETENTION POSTOPERATIVE	0/812 (0%)
VASCULAR PSEUDOANEURYSM	2/812 (0.2%)
WOUND DEHISCENCE	1/812 (0.1%)
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED	18/812 (2.2%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED	39/812 (4.8%)
BLOOD CREATININE INCREASED	2/812 (0.2%)
BLOOD GLUCOSE INCREASED	3/812 (0.4%)
BLOOD PRESSURE ABNORMAL	1/812 (0.1%)
BLOOD PRESSURE DECREASED	1/812 (0.1%)
BLOOD PRESSURE INCREASED	1/812 (0.1%)
BLOOD PRESSURE SYSTOLIC INCREASED	3/812 (0.4%)
C-REACTIVE PROTEIN INCREASED	2/812 (0.2%)
CARCINOEMBRYONIC ANTIGEN INCREASED	0/812 (0%)
CARDIAC ENZYMES INCREASED	50/812 (6.2%)
CARDIAC STRESS TEST ABNORMAL	0/812 (0%)
ELECTROCARDIOGRAM ST SEGMENT ELEVATION	2/812 (0.2%)
FEMORAL BRUIT	1/812 (0.1%)
GLYCOSYLATED HAEMOGLOBIN INCREASED	2/812 (0.2%)
HEART RATE INCREASED	1/812 (0.1%)
HEPATIC ENZYME INCREASED	3/812 (0.4%)
INTERNATIONAL NORMALISED RATIO INCREASED	1/812 (0.1%)
LIVER FUNCTION TEST ABNORMAL	2/812 (0.2%)
LOW DENSITY LIPOPROTEIN INCREASED	1/812 (0.1%)
OXYGEN SATURATION DECREASED	2/812 (0.2%)
RED BLOOD CELL SEDIMENTATION RATE INCREASED	1/812 (0.1%)
TROPONIN I INCREASED	43/812 (5.3%)
TROPONIN INCREASED	71/812 (8.7%)
TROPONIN T INCREASED	31/812 (3.8%)
Metabolism and nutrition disorders
DIABETES MELLITUS	9/812 (1.1%)
DYSLIPIDAEMIA	1/812 (0.1%)
FLUID RETENTION	1/812 (0.1%)
GLUCOSE TOLERANCE IMPAIRED	1/812 (0.1%)
GOUT	2/812 (0.2%)
HYPERGLYCAEMIA	1/812 (0.1%)
HYPERKALAEMIA	1/812 (0.1%)
HYPONATRAEMIA	1/812 (0.1%)
IRON DEFICIENCY	1/812 (0.1%)
TYPE 2 DIABETES MELLITUS	2/812 (0.2%)
VITAMIN D DEFICIENCY	1/812 (0.1%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	6/812 (0.7%)
ARTHRITIS	1/812 (0.1%)
BACK PAIN	17/812 (2.1%)
BURSITIS	1/812 (0.1%)
COSTOCHONDRITIS	1/812 (0.1%)
INTERVERTEBRAL DISC DEGENERATION	1/812 (0.1%)
INTERVERTEBRAL DISC PROTRUSION	0/812 (0%)
JAW CYST	0/812 (0%)
JOINT SWELLING	1/812 (0.1%)
MUSCLE SPASMS	1/812 (0.1%)
MUSCULAR WEAKNESS	1/812 (0.1%)
MUSCULOSKELETAL CHEST PAIN	1/812 (0.1%)
MUSCULOSKELETAL DISCOMFORT	0/812 (0%)
MUSCULOSKELETAL PAIN	3/812 (0.4%)
MUSCULOSKELETAL STIFFNESS	1/812 (0.1%)
MYALGIA	4/812 (0.5%)
NECK PAIN	3/812 (0.4%)
OSTEOARTHRITIS	2/812 (0.2%)
PAIN IN EXTREMITY	7/812 (0.9%)
POLYARTHRITIS	0/812 (0%)
SPINAL COLUMN STENOSIS	0/812 (0%)
SPINAL OSTEOARTHRITIS	1/812 (0.1%)
SPONDYLITIS	1/812 (0.1%)
TENDONITIS	1/812 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA	1/812 (0.1%)
BONE NEOPLASM	0/812 (0%)
BREAST CANCER	0/812 (0%)
COLON CANCER	0/812 (0%)
HAIR FOLLICLE TUMOUR BENIGN	1/812 (0.1%)
HEPATIC NEOPLASM MALIGNANT	0/812 (0%)
HODGKIN'S DISEASE	0/812 (0%)
LARYNGEAL CANCER	0/812 (0%)
LUNG NEOPLASM	1/812 (0.1%)
LUNG NEOPLASM MALIGNANT	0/812 (0%)
MALIGNANT MELANOMA	0/812 (0%)
MEDIASTINUM NEOPLASM	0/812 (0%)
MESOTHELIOMA	0/812 (0%)
METASTASES TO CENTRAL NERVOUS SYSTEM	0/812 (0%)
MULTIPLE MYELOMA	0/812 (0%)
NEOPLASM MALIGNANT	0/812 (0%)
PROSTATE CANCER	1/812 (0.1%)
RENAL CANCER	0/812 (0%)
RETROPERITONEAL NEOPLASM	0/812 (0%)
SKIN CANCER	1/812 (0.1%)
SOFT TISSUE NEOPLASM	1/812 (0.1%)
VULVAL CANCER	0/812 (0%)
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS	0/812 (0%)
BALANCE DISORDER	1/812 (0.1%)
BURNING SENSATION	1/812 (0.1%)
CAROTID ARTERY STENOSIS	1/812 (0.1%)
CARPAL TUNNEL SYNDROME	2/812 (0.2%)
CEREBRAL HAEMATOMA	0/812 (0%)
CEREBRAL INFARCTION	0/812 (0%)
CEREBROVASCULAR ACCIDENT	0/812 (0%)
DEMENTIA	1/812 (0.1%)
DIZZINESS	12/812 (1.5%)
DIZZINESS POSTURAL	3/812 (0.4%)
ENCEPHALITIS	0/812 (0%)
EXERTIONAL HEADACHE	1/812 (0.1%)
HEADACHE	18/812 (2.2%)
HYPOAESTHESIA	3/812 (0.4%)
ISCHAEMIC STROKE	0/812 (0%)
LETHARGY	1/812 (0.1%)
LOSS OF CONSCIOUSNESS	0/812 (0%)
LUMBAR RADICULOPATHY	0/812 (0%)
MIGRAINE	1/812 (0.1%)
PARAESTHESIA	3/812 (0.4%)
PARKINSON'S DISEASE	1/812 (0.1%)
PARKINSONISM	0/812 (0%)
PRESYNCOPE	13/812 (1.6%)
SYNCOPE	6/812 (0.7%)
TRANSIENT ISCHAEMIC ATTACK	3/812 (0.4%)
TREMOR	2/812 (0.2%)
Psychiatric disorders
ABNORMAL BEHAVIOUR	0/812 (0%)
ANXIETY	4/812 (0.5%)
CONFUSIONAL STATE	1/812 (0.1%)
DELIRIUM	1/812 (0.1%)
DEPRESSION	1/812 (0.1%)
INSOMNIA	3/812 (0.4%)
MAJOR DEPRESSION	0/812 (0%)
MANIA	0/812 (0%)
MENTAL DISORDER	0/812 (0%)
MOOD SWINGS	1/812 (0.1%)
NERVOUSNESS	2/812 (0.2%)
PANIC ATTACK	1/812 (0.1%)
RESTLESSNESS	1/812 (0.1%)
SUICIDE ATTEMPT	0/812 (0%)
Renal and urinary disorders
BLADDER DILATATION	1/812 (0.1%)
BLADDER OBSTRUCTION	0/812 (0%)
CALCULUS URINARY	0/812 (0%)
DYSURIA	2/812 (0.2%)
POLLAKIURIA	1/812 (0.1%)
RENAL ARTERY STENOSIS	0/812 (0%)
RENAL COLIC	1/812 (0.1%)
RENAL FAILURE	2/812 (0.2%)
RENAL FAILURE ACUTE	1/812 (0.1%)
RENAL IMPAIRMENT	1/812 (0.1%)
RENAL MASS	0/812 (0%)
URETHRAL STENOSIS	1/812 (0.1%)
URINARY TRACT OBSTRUCTION	0/812 (0%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA	2/812 (0.2%)
BREAST CALCIFICATIONS	1/812 (0.1%)
GYNAECOMASTIA	1/812 (0.1%)
MENORRHAGIA	1/812 (0.1%)
UTERINE POLYP	1/812 (0.1%)
VAGINAL HAEMORRHAGE	0/812 (0%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA	0/812 (0%)
ACUTE RESPIRATORY FAILURE	0/812 (0%)
ASTHMA	0/812 (0%)
BRONCHITIS CHRONIC	1/812 (0.1%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	3/812 (0.4%)
COUGH	14/812 (1.7%)
DYSPNOEA	17/812 (2.1%)
DYSPNOEA EXERTIONAL	10/812 (1.2%)
EPISTAXIS	3/812 (0.4%)
HAEMOPTYSIS	2/812 (0.2%)
HAEMOTHORAX	1/812 (0.1%)
LUNG DISORDER	1/812 (0.1%)
NOCTURNAL DYSPNOEA	1/812 (0.1%)
PLEURAL EFFUSION	1/812 (0.1%)
PLEURISY	1/812 (0.1%)
PNEUMONIA ASPIRATION	0/812 (0%)
PRODUCTIVE COUGH	1/812 (0.1%)
PULMONARY EMBOLISM	0/812 (0%)
PULMONARY OEDEMA	0/812 (0%)
RALES	1/812 (0.1%)
RESPIRATORY DISTRESS	0/812 (0%)
RESPIRATORY FAILURE	0/812 (0%)
SLEEP APNOEA SYNDROME	2/812 (0.2%)
Skin and subcutaneous tissue disorders
DRUG ERUPTION	2/812 (0.2%)
ECCHYMOSIS	3/812 (0.4%)
ECZEMA	3/812 (0.4%)
IDIOPATHIC URTICARIA	1/812 (0.1%)
INCREASED TENDENCY TO BRUISE	2/812 (0.2%)
NIGHT SWEATS	1/812 (0.1%)
PRURITUS	2/812 (0.2%)
PRURITUS GENERALISED	2/812 (0.2%)
PSORIASIS	1/812 (0.1%)
RASH	8/812 (1%)
RASH GENERALISED	1/812 (0.1%)
RASH PRURITIC	2/812 (0.2%)
SKIN DISCOLOURATION	1/812 (0.1%)
SKIN LESION	1/812 (0.1%)
SKIN ULCER	1/812 (0.1%)
URTICARIA	2/812 (0.2%)
Social circumstances
OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS	1/812 (0.1%)
Surgical and medical procedures
CARDIAC ABLATION	0/812 (0%)
CARDIAC PACEMAKER INSERTION	0/812 (0%)
CHOLECYSTECTOMY	0/812 (0%)
FLUID REPLACEMENT	0/812 (0%)
PERIPHERAL ARTERY ANGIOPLASTY	0/812 (0%)
PROSTATECTOMY	0/812 (0%)
TOOTH EXTRACTION	1/812 (0.1%)
URETHRAL STENT REMOVAL	0/812 (0%)
VASECTOMY	1/812 (0.1%)
Vascular disorders
AORTIC ANEURYSM	0/812 (0%)
BLOOD PRESSURE INADEQUATELY CONTROLLED	1/812 (0.1%)
HAEMATOMA	3/812 (0.4%)
HAEMORRHAGE	2/812 (0.2%)
HYPERTENSION	18/812 (2.2%)
HYPERTENSIVE CRISIS	3/812 (0.4%)
HYPERTENSIVE EMERGENCY	0/812 (0%)
HYPOTENSION	17/812 (2.1%)
ILIAC ARTERY OCCLUSION	0/812 (0%)
INTERMITTENT CLAUDICATION	1/812 (0.1%)
ORTHOSTATIC HYPOTENSION	1/812 (0.1%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	1/812 (0.1%)
PERIPHERAL COLDNESS	1/812 (0.1%)
PERIPHERAL ISCHAEMIA	0/812 (0%)
PERIPHERAL VASCULAR DISORDER	0/812 (0%)
SUBCLAVIAN ARTERY STENOSIS	0/812 (0%)
VENOUS INSUFFICIENCY	0/812 (0%)
VENOUS THROMBOSIS	1/812 (0.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Susan Veldhof
Organization	Abbott Vascular International BVBA
Phone	+31653428610
Email	susan.veldhof@av.abbott.com

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01023789

Other Study ID Numbers:

09-386
ACTRN12610000131055
REFCTRI000460, 03-05-2010

First Posted:

Dec 2, 2009

Last Update Posted:

Feb 14, 2018

Last Verified:

Dec 1, 2017