Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02229864
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Duration (Months): 65
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only receive Absorb BVS with a maximum of two de novo native coronary artery lesions after implantation of the Absorb BVS.

Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III RCT primary endpoint.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Artery Stenosis; Coronary Disease; Coronary Stenosis	Device: Coronary artery stenting: Absorb BVS	N/A

Detailed Description

To ensure the PK measurements reflect everolimus exposure due to Absorb BVS only, the PK sub-study will not allow non-target lesion treatment.

Blood Sampling Timing:

• Pre-Absorb BVS implantation: Baseline

o Baseline is defined as prior to implantation of the first Absorb BVS; the blood sample will be drawn on the day of the index procedure either through a heparin lock, venous sheath, or venipuncture.

• Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 24 hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs (4 days), 120 hrs (5 days), 168 hrs (7 days), 336 hrs (14 days), and 720 hrs (30 days).

• Post-implantation blood samples will be drawn at the time intervals stated above; timing of the post-implantation sampling will begin when the last Absorb BVS is deployed, i.e. last Absorb BVS delivery catheter is removed from the body.

Pharmacokinetic (PK) parameters will include time to maximum concentration (tmax); maximum concentration (Cmax); AUC24h: Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS; AUClast: Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration; AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time; terminal elimination rate constant (λz); terminal elimination half-life (t1/2term); drug clearance (CL).

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ABSORB III RCT Pharmacokinetics (PK) Sub-study
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coronary artery stenting: Absorb BVS Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)	Device: Coronary artery stenting: Absorb BVS; Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm

Outcome Measures

Primary Outcome Measures

1. Maximum Concentration (Cmax) [0 to 30 days]

   Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

2. Time of Maximum (Tmax) [0 to 30 days]

   Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

3. AUC24h [0 to 24 hours]

   Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.

4. AUC Last [0 to 30 days]

   Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.

5. AUC 0-infinity [0 to 30 days]

   AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100

6. Terminal Elimination Rate Constant (λz) [0 to 30 days]

   The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.

7. Terminal Elimination Half-life (t1/2term) [0 to 30 days]

   The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz.

8. Drug Clearance (CL) [0 to 30 days]

   The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ .

Secondary Outcome Measures

1. Number of Participants With Target Lesion Failure (TLF) [0 to 1853 Days]

   Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).

2. Number of Participants With All Death [0 to 1853 Days]

   All death includes cardiac death, vascular death, and non-cardiac death.

3. Number of Participants With All Myocardial Infarction (MI) [0 to 1853 Days]

   All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).

4. Number of Participants With All Target Lesion Revascularization (TLR) [0 to 1853 Days]

   All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).

5. Number of Participants With All Target Vessel Revascularization (TVR) [0 to 1853 Days]

   All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).

6. Number of Participants With All Revascularization [0 to 1853 Days]

   All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.

7. Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable) [≤ 1 day]

   Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

8. Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable) [>1 to 30 days]

   Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

9. Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable) [31 to 393 days]

   Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

10. Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable) [0 to 1853 Days]

    Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

General Inclusion Criteria:

1. 18 years of age.

2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

3. Evidence of myocardial. In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.

4. An acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure.

6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.

7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

1. One or two de novo target lesions:

2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.

3. The definition of epicardial vessels means the left anterior descending (LAD), left coronary artery (LCX), and right coronary artery (RCA) and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.

4. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve (FFR), stress test), unstable angina or post-infarct angina.

5. Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.

6. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate receptor (ADP) antagonist is planned within 12 months after the procedure.

2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.

4. Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.

5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

7. Subject requires coumadin or any other agent for chronic oral anticoagulation

8. Subject is likely to become hemodynamically unstable due to their arrhythmia

9. Subject has poor survival prognosis due to their arrhythmia

10. Subject has a left ventricular ejection fraction (LVEF) < 30%

11. Subject has undergone prior percutaneous coronary intervention (PCI) within the target vessel(s) during the last 12 months.

12. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure.

13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

14. At the time of screening, the subject has a malignancy that is not in remission.

15. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.

16. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.

17. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).

18. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

19. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.

20. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.

21. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.

22. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).

23. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.

24. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.

25. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.

26. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

27. Subject is part of a vulnerable population

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

1. Lesion which prevents successful balloon pre-dilatation

2. Lesion is located in left main.

3. Aorto-ostial RCA lesion.

4. Lesion located within 3 mm of the origin of the LAD or LCX.

5. Lesion involving a bifurcation with a:

6. side branch ≥ 2 mm in diameter, or

7. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or

8. side branch requiring dilatation.

9. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS.

10. Vessel contains thrombus as indicated in the angiographic images or by intravascular ultrasound (IVUS) or optical coherence tomography (OCT).

11. Lesion or vessel involves a myocardial bridge.

12. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS would need to cross the stent to reach the target lesion.

13. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.

14. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Healthcare	Scottsdale	Arizona	United States	85258
2	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan	United States	49770

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: David G. Rizik, MD, Scottsdale Healthcare, Scottsdale, AZ
• Principal Investigator: Louis A. Cannon, MD, Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 16, 2018

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02229864
• Other Study ID Numbers: 10-392 B
• First Posted: Sep 3, 2014
• Last Update Posted: Mar 12, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Abbott Medical Devices: Absorb™ BVS; Angioplasty; Bioabsorbable; BVS; Coronary Artery Disease; Coronary Artery Endothelial Responsiveness; Coronary artery restenosis; Coronary artery stenosis; Coronary scaffold; Coronary Stent; Drug eluting stents; Everolimus; Myocardial ischemia; Stent thrombosis; Stents
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014.
Pre-assignment Detail	In this sub-study, subjects received either one (N=8) or two (N=4) Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm • Scaffold lengths: 8, 12, 18, and 28 mm
Period Title: Overall Study
STARTED	12
COMPLETED	9
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm • Scaffold lengths: 8, 12, 18, and 28 mm
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.1 (10.5)
Sex: Female, Male (Count of Participants)
Female	1 8.3%
Male	11 91.7%
Region of Enrollment (Count of Participants)
United States	12 100%
Hypertension Requiring Medication (Count of Participants)
Count of Participants [Participants]	12 100%
Dyslipidemia Requiring Medication (Count of Participants)
Count of Participants [Participants]	12 100%
Prior Coronary Intervention (Count of Participants)
Count of Participants [Participants]	1 8.3%
Stable Angina (Count of Participants)
Count of Participants [Participants]	9 75%

Outcome Measures

1. Primary Outcome

Title	Maximum Concentration (Cmax)
Description	Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [nanograms per milliliter]	2.397

2. Primary Outcome

Title	Time of Maximum (Tmax)
Description	Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [Hours]	0.55

3. Primary Outcome

Title	AUC24h
Description	Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.
Time Frame	0 to 24 hours

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [ng*h/mL]	22.67

4. Primary Outcome

Title	AUC Last
Description	Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [ng*h/mL]	55.90

5. Primary Outcome

Title	AUC 0-infinity
Description	AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [ng*h/mL]	72.02

6. Primary Outcome

Title	Terminal Elimination Rate Constant (λz)
Description	The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [1/hour]	0.01092

7. Primary Outcome

Title	Terminal Elimination Half-life (t1/2term)
Description	The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [Hours]	63.5

8. Primary Outcome

Title	Drug Clearance (CL)
Description	The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ .
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Median (Full Range) [Liter/hour]	3.451

9. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	2 16.7%

10. Secondary Outcome

Title	Number of Participants With All Death
Description	All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	2 16.7%

11. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI)
Description	All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	4 33.3%

12. Secondary Outcome

Title	Number of Participants With All Target Lesion Revascularization (TLR)
Description	All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	0 0%

13. Secondary Outcome

Title	Number of Participants With All Target Vessel Revascularization (TVR)
Description	All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	1 8.3%

14. Secondary Outcome

Title	Number of Participants With All Revascularization
Description	All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	3 25%

15. Secondary Outcome

Title	Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)
Description	Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame	≤ 1 day

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Count of Participants [Participants]	0 0%

16. Secondary Outcome

Title	Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)
Description	Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame	>1 to 30 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Count of Participants [Participants]	0 0%

17. Secondary Outcome

Title	Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)
Description	Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame	31 to 393 days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	12
Count of Participants [Participants]	0 0%

18. Secondary Outcome

Title	Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)
Description	Scaffold/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. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Time Frame	0 to 1853 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame.

Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS). Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Measure Participants	11
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	5 years
Arm/Group Title	Coronary Artery Stenting: Absorb BVS
Arm/Group Description	Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm • Scaffold lengths: 8, 12, 18, and 28 mm
All Cause Mortality
	Coronary Artery Stenting: Absorb BVS
	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)
Serious Adverse Events
	Coronary Artery Stenting: Absorb BVS
	Affected / at Risk (%)	# Events
Total	10/12 (83.3%)
Cardiac disorders
ANGINA PECTORIS	1/12 (8.3%)
ANGINA PECTORIS AGGRAVATED	1/12 (8.3%)
ARRHYTHMIA	1/12 (8.3%)
ATRIAL FIBRILLATION AGGRAVATED	1/12 (8.3%)
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE	1/12 (8.3%)
NON STEMI	1/12 (8.3%)
STABLE ANGINA PECTORIS	1/12 (8.3%)
UNSTABLE ANGINA	1/12 (8.3%)
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION	1/12 (8.3%)
UPPER GASTROINTESTINAL BLEEDING	1/12 (8.3%)
General disorders
CHEST PAIN	1/12 (8.3%)
CHEST PAIN (NON-CARDIAC)	1/12 (8.3%)
Infections and infestations
BRONCHITIS	1/12 (8.3%)
CELLULITIS	1/12 (8.3%)
CELLULITIS OF LEG	1/12 (8.3%)
SEPSIS	1/12 (8.3%)
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS	1/12 (8.3%)
IN-STENT CORONARY ARTERY RESTENOSIS	1/12 (8.3%)
SPINAL COMPRESSION FRACTURE	1/12 (8.3%)
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS	3/12 (25%)
PAINFULL ARM	1/12 (8.3%)
SPINAL STENOSIS OF LUMBAR REGION	1/12 (8.3%)
Renal and urinary disorders
ACUTE ON CHRONIC RENAL FAILURE	1/12 (8.3%)
ACUTE RENAL FAILURE	1/12 (8.3%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERTROPHY	1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA	1/12 (8.3%)
Vascular disorders
POPLITEAL VEIN THROMBOSIS	1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	Coronary Artery Stenting: Absorb BVS
	Affected / at Risk (%)	# Events
Total	12/12 (100%)
Cardiac disorders
ANGINA PECTORIS	3/12 (25%)
ANGINA PECTORIS AGGRAVATED	1/12 (8.3%)
ARRHYTHMIA	1/12 (8.3%)
ATRIAL FIBRILLATION	1/12 (8.3%)
ATRIAL FIBRILLATION AGGRAVATED	1/12 (8.3%)
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE	1/12 (8.3%)
BRADYCARDIA	1/12 (8.3%)
CHEST PAIN - CARDIAC	2/12 (16.7%)
CONGESTIVE HEART FAILURE	1/12 (8.3%)
CORONARY ARTERY DISSECTION	3/12 (25%)
CORONARY NO-REFLOW PHENOMENON	1/12 (8.3%)
NON STEMI	1/12 (8.3%)
STABLE ANGINA PECTORIS	1/12 (8.3%)
UNSTABLE ANGINA	1/12 (8.3%)
Gastrointestinal disorders
HEARTBURN	1/12 (8.3%)
SMALL BOWEL OBSTRUCTION	1/12 (8.3%)
TOOTHACHE	1/12 (8.3%)
UPPER GASTROINTESTINAL BLEEDING	1/12 (8.3%)
General disorders
CHEST PAIN	1/12 (8.3%)
CHEST PAIN (NON-CARDIAC)	4/12 (33.3%)
INFUSION SITE HEMATOMA	1/12 (8.3%)
Infections and infestations
BRONCHITIS	2/12 (16.7%)
CELLULITIS	1/12 (8.3%)
CELLULITIS OF LEG	1/12 (8.3%)
SEPSIS	1/12 (8.3%)
Injury, poisoning and procedural complications
BRUISE	1/12 (8.3%)
CORONARY ARTERY RESTENOSIS	1/12 (8.3%)
IN-STENT CORONARY ARTERY RESTENOSIS	1/12 (8.3%)
POST PROCEDURAL MYOCARDIAL INFARCTION	1/12 (8.3%)
POSTOPERATIVE HYPOTENSION	1/12 (8.3%)
SPINAL COMPRESSION FRACTURE	1/12 (8.3%)
TICK BITE	1/12 (8.3%)
URINARY RETENTION POSTOPERATIVE	1/12 (8.3%)
Investigations
CARDIAC ENZYMES INCREASED	2/12 (16.7%)
CREATINE KINASE MB INCREASED	3/12 (25%)
Musculoskeletal and connective tissue disorders
BACK PAIN AGGRAVATED	1/12 (8.3%)
COSTOCHONDRITIS	1/12 (8.3%)
LUMBAR SPINAL STENOSIS	3/12 (25%)
MONOARTHRITIS	1/12 (8.3%)
MUSCULOSKELETAL CHEST PAIN	1/12 (8.3%)
PAINFUL L ARM	1/12 (8.3%)
SPINAL STENOSIS OF LUMBAR REGION	1/12 (8.3%)
Nervous system disorders
DIZZINESS	1/12 (8.3%)
SCIATICA	1/12 (8.3%)
Renal and urinary disorders
ACUTE ON CHRONIC RENAL FAILURE	1/12 (8.3%)
ACUTE RENAL FAILURE	1/12 (8.3%)
URINARY RETENTION	1/12 (8.3%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERTROPHY	1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL	1/12 (8.3%)
HYPOXIA	1/12 (8.3%)
OBSTRUCTIVE SLEEP APNEA SYNDROME	1/12 (8.3%)
PULMONARY EDEMA	1/12 (8.3%)
SHORTNESS OF BREATH	1/12 (8.3%)
Vascular disorders
HYPOTENSION	1/12 (8.3%)
POPLITEAL VEIN THROMBOSIS	1/12 (8.3%)
SLOW REFLOW PHENOMENON	1/12 (8.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Principal Investigators shall not present or publish, nor submit for publication, any work resulting from the Services without Sponsor's prior written approval. Except as specifically set forth herein, neither party shall use the other party's name or trademark, or the name nor trademark of such other party's affiliate, in any publicity, advertising or announcement, or disclose the existence or terms of this Agreement, without the consenting party's prior written approval.