Absorb GT1 Japan PMS
Study Details
Study Description
Brief Summary
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The surveillance consists of two phases as detailed below. All patients will be continuously registered in each phases.
Phase 1 (All- patients): Includes 250 patients (approximately 45 sites)
Main Purpose: To confirm the efficacy of physician training and to establish optimal training for increasing medical institutions participating in post-marketing evaluation. Procedural results will be evaluated sequentially for early feedback to the sites. Therefore, there will be no quantitative goal established to move to Phase 2. However, recommended procedure may be updated as required in order to achieve optimal acute result.
Phase 2 (All- patients): Until 2000 patients are registered (up to 200 sites) Main Purpose:
To confirm safety.
Target sample size of the Surveillance is approximately 2,000 patients. Commercial sale of Absorb GT1 beyond the purpose of the Surveillance will be started if the scaffold thrombosis (ST) rate in the 2,000 patients at 3 month is 0.9% or lower (ST rates for patients with Absorb GT1).
In the ABSORB III (NCT01751906) clinical trial, 19 events of definite/probable ST reported through 1 year, and 18 of them except 1 occurred within 3 months (maximum of 78 days) post-procedure. Therefore, it is appropriate to perform interim analysis for the safety using ST rate through 3 months. The event occurred after 3 months was reported 362 days after the procedure, and the patient stopped treatment with thienopyridine antiplatelet agent on Day 356.
Both in the AVJ-301 (NCT01844284) and the ABSORB III clinical trials, ST rate through 1 year was 1.5%. In the ABSORB III clinical trial, ST rate in target lesion with Reference Vessel Diameter (RVD) ≥ 2.25 mm was 0.9%. As explained above, ST rates at 3 months and 1 year are almost similar. The half widths of the 95% confidence intervals (CI) to different sample sizes are presented in the table 2.3-1. The half width of 95% CI decreases from 0.6% to 0.4% when a sample size is increased from 1,000 to 2,000. However, further increase in the sample size does not result in significant decrease in the half width of 95% CI. Therefore, the sample size of the Surveillance was established as 2,000 patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Absorb GT1 BVS Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
Device: ABSORB GT1 BVS
Patients receiving Absorb GT1 BVS
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Acute Scaffold Thrombosis (ST) [Day 0]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Sub Acute Scaffold Thrombosis (ST) [>1 to 30 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Late Scaffold Thrombosis (ST) [31 to 90 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Late Scaffold Thrombosis (ST) [31 to 365 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Very Late Scaffold Thrombosis (ST) [366 to 730 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Overall Scaffold Thrombosis (ST) [0 to 90 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Cumulative Scaffold Thrombosis [0 to 90 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Cumulative Scaffold Thrombosis [0 to 730 days]
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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
- Number of Participants With Exclusion of Very Small Vessels [During index procedure, "54.8 ± 27.6 min"]
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1.
- Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging [During index procedure, "54.8 ± 27.6 min"]
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
- Number of Participants With Composite of Device Deficiencies [During index procedure, "54.8 ± 27.6 min"]
Device deficiencies: Number of participants with at least one of the following Device deficiencies Lesion/implant failure Delivery difficulty (finally delivered) Re-crossing failure Re-crossing difficulty Post-dilatation balloon Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) Instruction for Use (IFU) not included Major Strut Malapposition Strut Fracture within 6 months
Secondary Outcome Measures
- Number of All Death (Cardiac, Vascular, Non-Cardiovascular) [0 to 30 days]
Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of All Death (Cardiac, Vascular, Non-Cardiovascular) [0 to 90 days]
Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of All Death (Cardiac, Vascular, Non-Cardiovascular) [0 to 1 year]
Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of All Death (Cardiac, Vascular, Non-Cardiovascular) [0 to 2 years]
Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Number of Participants With All Myocardial Infarction (MI) [0 to 30 days]
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
- Number of Participants With All Myocardial Infarction (MI) [0 to 90 days]
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
- Number of Participants With All Myocardial Infarction (MI) [0 to 1 year]
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
- Number of Participants With All Myocardial Infarction (MI) [0 to 2 years]
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
- Number of Participants With All Target Lesion Revascularization (TLR) [0 to 30 days]
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
- Number of Participants With All Target Lesion Revascularization (TLR) [0 to 90 days]
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
- Number of Participants With All Target Lesion Revascularization (TLR) [0 to 1 year]
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
- Number of Participants With All Target Lesion Revascularization (TLR) [0 to 2 years]
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
- Number of Participants With All Target Vessel Revascularization (TVR) [0 to 30 days]
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
- Number of Participants With All Target Vessel Revascularization (TVR) [0 to 90 days]
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
- Number of Participants With All Target Vessel Revascularization (TVR) [0 to 1 year]
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
- Number of Participants With All Target Vessel Revascularization (TVR) [0 to 2 years]
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
- Number of Participants With All Coronary Revascularization [0 to 30 days]
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
- Number of Participants With All Coronary Revascularization [0 to 90 days]
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
- Number of Participants With All Coronary Revascularization [0 to 1 year]
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
- Number of Participants With All Coronary Revascularization [0 to 2 years]
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
- Number of Death/MI/All Revascularization (DMR) [0 to 30 days]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
- Number of Death/MI/All Revascularization (DMR) [0 to 90 days]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
- Number of Death/MI/All Revascularization (DMR) [0 to 1 year]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
- Number of Death/MI/All Revascularization (DMR) [0 to 2 years]
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
- Number of Participants With Target Vessel Failure (TVF) [0 to 30 days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants With Target Vessel Failure (TVF) [0 to 90 days]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
- Number of Participants With Target Vessel Failure (TVF) [0 to 1 Year]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
- Number of Participants With Target Vessel Failure (TVF) [0 to 2 years]
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
- Number of Major Adverse Cardiac Event (MACE) [0 to 30 days]
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
- Number of Major Adverse Cardiac Event (MACE) [0 to 90 days]
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
- Number of Major Adverse Cardiac Event (MACE) [0 to 1 year]
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
- Number of Major Adverse Cardiac Event (MACE) [0 to 2 years]
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
- Number of Cardiac Death/TV-MI/ID-TLR (TLF) [0 to 30 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Cardiac Death/TV-MI/ID-TLR (TLF) [0 to 90 days]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Cardiac Death/TV-MI/ID-TLR (TLF) [0 to 1 year]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Cardiac Death/TV-MI/ID-TLR (TLF) [0 to 2 years]
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
- Number of Participants With Cardiac Death/Myocardial Infarction (MI) [0 to 30 days]
Cardiac death: 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 Cardiac Death/Myocardial Infarction (MI) [0 to 90 days]
Cardiac death: 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 Cardiac Death/Myocardial Infarction (MI) [0 to 1 year]
Cardiac death: 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 Cardiac Death/Myocardial Infarction (MI) [0 to 2 years]
Cardiac death: 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.
- Angiographic Endpoints (Core Lab Analysis): Lesion Morphology [Pre-procedure]
- Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow [Pre-procedure]
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
- Angiographic Endpoints (Core Lab Analysis): Lesion Length [Pre-procedure]
Lesion Length (can be measured after successful post-dilatation)
- Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) [Pre-procedure]
Proximal RVD (can be measured after successful post-dilatation)
- Angiographic Endpoints (Core Lab Analysis): Distal RVD [Pre-procedure]
Distal RVD (can be measured after successful post-dilatation)
- Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD) [Pre-procedure]
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
- Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS) [Pre-procedure]
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
- Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
- Angiographic Endpoints (Core Lab Analysis): MLD (In-segment) [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
- Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment ) [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
- Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment ) [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
- IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) [Pre-procedure (or after pre-dilatation)]
- IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
- IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
- IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
- IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture [Post-procedure (average procedure time of "54.8 ± 27.6 min")]
Strut fracture will be measured as either number or percentage post-procedure
Eligibility Criteria
Criteria
Inclusion Criteria:
- General Percutaneous coronary intervention (PCI) population.
Exclusion Criteria:
- No specific exclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nagoya Daini Red Cross Hospital | Nagoya | Aichi | Japan | 466-8650 |
| 2 | Shin Tokyo Hospital | Matsudo | Chiba | Japan | 270-2232 |
| 3 | Shin Koga Hospital | Kurume | Fukuoka | Japan | 830-8577 |
| 4 | Hanaoka Seishu Memorial Cardiovascular Clinic | Sapporo | Hokkaido | Japan | 062-0003 |
| 5 | Kobe University | Kobe | Hyogo | Japan | 650-0017 |
| 6 | Iwate Medical University | Morioka | Iwate | Japan | 020-8505 |
| 7 | Shonan Kamakura General Hospital | Kamakura | Kanagawa | Japan | 247-8533 |
| 8 | Kurashiki Central Hospital | Kurashiki | Okayama | Japan | 710-8602 |
| 9 | Saitama Sekishinkai Hospital | Sayama | Saitama | Japan | 350-1323 |
| 10 | Mitsui Memorial Museum | Chiyoda | Tokyo | Japan | 101-8643 |
| 11 | Teikyo University | Itabashi | Tokyo | Japan | 173-8606 |
| 12 | Toho University Ohashi Medical Center | Meguro | Tokyo | Japan | 153-8515 |
| 13 | Saiseikai Kumamoto Hospital | Kumamoto | Japan | 861-4193 | |
| 14 | Miyazaki Medical Association Hospital | Miyazaki | Japan | 880-0834 | |
| 15 | Sakurabashi Watanabe Hospital | Osaka | Japan | 530-0001 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Masato Nakamura, MD, Toho University Ohashi Medical Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 16-310
Study Results
Participant Flow
| Recruitment Details | This Post-marketing Surveillance study was conducted in patients with ischemic heart disease potentially indicated for treatment with the Absorb GT1 Bioresorbable Vascular Scaffold System. A total of 135 patients were enrolled between December 13, 2016 to December 11, 2017 time period. |
|---|---|
| Pre-assignment Detail | The proposed target sample size of the surveillance was approximately 2,000 patients. However, only 135 patients were registered in this study since Absorb GT1 was withdrawn from global market, due to low sales volume. |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Period Title: Overall Study | |
| STARTED | 135 |
| COMPLETED | 132 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Overall Participants | 135 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
64.0
(10.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
21
15.6%
|
| Male |
114
84.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
0
0%
|
| Unknown or Not Reported |
135
100%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
135
100%
|
| Region of Enrollment (participants) [Number] | |
| Japan |
135
100%
|
| Diabetes Mellitus (Count of Participants) | |
| Count of Participants [Participants] |
53
39.3%
|
| Dyslipidemia (Count of Participants) | |
| Count of Participants [Participants] |
84
62.2%
|
| Hypertension (Count of Participants) | |
| Count of Participants [Participants] |
93
68.9%
|
| Renal Failure (Count of Participants) | |
| Count of Participants [Participants] |
5
3.7%
|
| Prior Coronary Intervention (Count of Participants) | |
| Count of Participants [Participants] |
35
25.9%
|
| Previous Myocardial Infarction (MI) (Count of Participants) | |
| Count of Participants [Participants] |
13
9.6%
|
Outcome Measures
| Title | Number of Participants With Acute Scaffold Thrombosis (ST) |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 | Day 0 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Sub Acute Scaffold Thrombosis (ST) |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Late Scaffold Thrombosis (ST) |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Late Scaffold Thrombosis (ST) |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 365 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Very Late Scaffold Thrombosis (ST) |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 | 366 to 730 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 133 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Overall Scaffold Thrombosis (ST) |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Cumulative Scaffold Thrombosis |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Cumulative Scaffold Thrombosis |
|---|---|
| Description | Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 730 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 133 |
| Definite |
0
0%
|
| Probable |
0
0%
|
| Definite/Probable |
0
0%
|
| Title | Number of Participants With Exclusion of Very Small Vessels |
|---|---|
| Description | For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD < 2.5 mm from registration by the last half of Phase 1. |
| Time Frame | During index procedure, "54.8 ± 27.6 min" |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (phase 1 participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| < 2.25 mm |
18
13.3%
|
| ≥ 2.25 mm - < 2.5 mm |
26
19.3%
|
| ≥ 2.5 mm - ≤ 3.5 mm |
91
67.4%
|
| > 3.5 mm |
4
3%
|
| Title | Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging |
|---|---|
| Description | IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab. |
| Time Frame | During index procedure, "54.8 ± 27.6 min" |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
5
3.7%
|
| Title | Number of Participants With Composite of Device Deficiencies |
|---|---|
| Description | Device deficiencies: Number of participants with at least one of the following Device deficiencies Lesion/implant failure Delivery difficulty (finally delivered) Re-crossing failure Re-crossing difficulty Post-dilatation balloon Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) Instruction for Use (IFU) not included Major Strut Malapposition Strut Fracture within 6 months |
| Time Frame | During index procedure, "54.8 ± 27.6 min" |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Lesion/implant failure |
0
0%
|
| Delivery difficulty (finally delivered) |
6
4.4%
|
| Re-crossing failure |
1
0.7%
|
| Re-crossing difficulty |
0
0%
|
| Post-dilatation balloon+OCT/IVUS |
11
8.1%
|
| IFU not included |
1
0.7%
|
| Major Strut Malapposition |
1
0.7%
|
| Strut Fracture within 6 months |
1
0.7%
|
| Title | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
|---|---|
| Description | Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
|---|---|
| Description | Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
|---|---|
| Description | Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of All Death (Cardiac, Vascular, Non-Cardiovascular) |
|---|---|
| Description | Cardiac death: 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. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
2
1.5%
|
| Title | Number of Participants With All Myocardial Infarction (MI) |
|---|---|
| Description | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With All Myocardial Infarction (MI) |
|---|---|
| Description | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With All Myocardial Infarction (MI) |
|---|---|
| Description | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With All Myocardial Infarction (MI) |
|---|---|
| Description | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI) |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With All Target Lesion Revascularization (TLR) |
|---|---|
| Description | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Target Lesion Revascularization (TLR) |
|---|---|
| Description | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Target Lesion Revascularization (TLR) |
|---|---|
| Description | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Target Lesion Revascularization (TLR) |
|---|---|
| Description | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
3
2.2%
|
| Title | Number of Participants With All Target Vessel Revascularization (TVR) |
|---|---|
| Description | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Target Vessel Revascularization (TVR) |
|---|---|
| Description | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Target Vessel Revascularization (TVR) |
|---|---|
| Description | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Target Vessel Revascularization (TVR) |
|---|---|
| Description | Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
4
3%
|
| Title | Number of Participants With All Coronary Revascularization |
|---|---|
| Description | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Coronary Revascularization |
|---|---|
| Description | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Participants With All Coronary Revascularization |
|---|---|
| Description | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
3
2.2%
|
| Title | Number of Participants With All Coronary Revascularization |
|---|---|
| Description | All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
9
6.7%
|
| Title | Number of Death/MI/All Revascularization (DMR) |
|---|---|
| Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Death/MI/All Revascularization (DMR) |
|---|---|
| Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Number of Death/MI/All Revascularization (DMR) |
|---|---|
| Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
3
2.2%
|
| Title | Number of Death/MI/All Revascularization (DMR) |
|---|---|
| Description | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
11
8.1%
|
| Title | Number of Participants With Target Vessel Failure (TVF) |
|---|---|
| Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Target Vessel Failure (TVF) |
|---|---|
| Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Target Vessel Failure (TVF) |
|---|---|
| Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR) |
| Time Frame | 0 to 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Target Vessel Failure (TVF) |
|---|---|
| Description | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR) |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
4
3%
|
| Title | Number of Major Adverse Cardiac Event (MACE) |
|---|---|
| Description | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Major Adverse Cardiac Event (MACE) |
|---|---|
| Description | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Major Adverse Cardiac Event (MACE) |
|---|---|
| Description | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Major Adverse Cardiac Event (MACE) |
|---|---|
| Description | MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR) |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
3
2.2%
|
| Title | Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
|---|---|
| Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Time Frame | 0 to 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
|---|---|
| Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Time Frame | 0 to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
|---|---|
| Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Time Frame | 0 to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Cardiac Death/TV-MI/ID-TLR (TLF) |
|---|---|
| Description | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Time Frame | 0 to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
3
2.2%
|
| Title | Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
|---|---|
| Description | Cardiac death: 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 |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
|---|---|
| Description | Cardiac death: 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 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
|---|---|
| Description | Cardiac death: 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 |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Cardiac Death/Myocardial Infarction (MI) |
|---|---|
| Description | Cardiac death: 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 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 134 |
| Count of Participants [Participants] |
1
0.7%
|
| Title | Angiographic Endpoints (Core Lab Analysis): Lesion Morphology |
|---|---|
| Description | |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| ACC/AHA Type B2/C |
51.8
|
| Severe/Moderate Calcification |
11.5
|
| Eccentric |
27.3
|
| Total Occlusion |
0.0
|
| Title | Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow |
|---|---|
| Description | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesion | 139 |
| 0 |
0.00
|
| 1 |
0.72
|
| 2 |
2.16
|
| 3 |
97.12
|
| Title | Angiographic Endpoints (Core Lab Analysis): Lesion Length |
|---|---|
| Description | Lesion Length (can be measured after successful post-dilatation) |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [mm] |
13.84
(4.74)
|
| Title | Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) |
|---|---|
| Description | Proximal RVD (can be measured after successful post-dilatation) |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 129 |
| Mean (Standard Deviation) [mm] |
3.15
(0.49)
|
| Title | Angiographic Endpoints (Core Lab Analysis): Distal RVD |
|---|---|
| Description | Distal RVD (can be measured after successful post-dilatation) |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 129 |
| Mean (Standard Deviation) [mm] |
2.95
(0.39)
|
| Title | Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD) |
|---|---|
| Description | Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [mm] |
1.00
(0.30)
|
| Title | Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS) |
|---|---|
| Description | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). |
| Time Frame | Pre-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [percentage of diameter] |
63.1
(9.5)
|
| Title | Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow |
|---|---|
| Description | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesion | 139 |
| 0 |
0.00
|
| 1 |
0.72
|
| 2 |
1.44
|
| 3 |
97.84
|
| Title | Angiographic Endpoints (Core Lab Analysis): MLD (In-segment) |
|---|---|
| Description | Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [mm] |
2.30
(0.38)
|
| Title | Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment ) |
|---|---|
| Description | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold. |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [percentage of diameter] |
18.4
(6.3)
|
| Title | Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment ) |
|---|---|
| Description | The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD). |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [mm] |
1.29
(0.44)
|
| Title | IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) |
|---|---|
| Description | |
| Time Frame | Pre-procedure (or after pre-dilatation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Proximal |
8.04
(2.51)
|
| Distal |
6.29
(2.30)
|
| Title | IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) |
|---|---|
| Description | |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Proximal |
8.21
(2.47)
|
| Distal |
6.54
(2.21)
|
| Title | IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area |
|---|---|
| Description | |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1). |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [mm^2] |
6.86
(1.77)
|
| Title | IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition |
|---|---|
| Description | Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Mean (Standard Deviation) [Percentage of lesions] |
1.89
(3.63)
|
| Title | IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture |
|---|---|
| Description | Strut fracture will be measured as either number or percentage post-procedure |
| Time Frame | Post-procedure (average procedure time of "54.8 ± 27.6 min") |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (all participants with Absorb GT1) |
| Arm/Group Title | Absorb GT1 BVS |
|---|---|
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. |
| Measure Participants | 135 |
| Measure Lesions | 139 |
| Yes |
1
|
| No |
138
|
Adverse Events
| Time Frame | 2 Years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Absorb GT1 BVS | |
| Arm/Group Description | Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System. | |
All Cause Mortality |
||
| Absorb GT1 BVS | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/135 (1.5%) | |
Serious Adverse Events |
||
| Absorb GT1 BVS | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/135 (8.1%) | |
| Cardiac disorders | ||
| MYOCARDIAL INFARCTION/ACS | 1/135 (0.7%) | |
| PAROXYSMAL ATRIAL FIBRILLATION | 1/135 (0.7%) | |
| STABLE ANGINA | 3/135 (2.2%) | |
| STABLE CORONARY DISEASE | 4/135 (3%) | |
| Gastrointestinal disorders | ||
| ACUTE INTESTINAL INFRAMMATION | 1/135 (0.7%) | |
| LARGE INTESTINE POLYP | 1/135 (0.7%) | |
| General disorders | ||
| DEATH UNKNOWN CAUSE | 1/135 (0.7%) | |
| Hepatobiliary disorders | ||
| ACUTE CHOLESYSTITIS | 1/135 (0.7%) | |
| CHOLECYSTITIS | 1/135 (0.7%) | |
| GALLSTONE ATTACK | 1/135 (0.7%) | |
| Infections and infestations | ||
| INFLUENZA B VIRAL INFECTION | 1/135 (0.7%) | |
| INFLUENZA VIRAL INFECTION | 1/135 (0.7%) | |
| URINARY TRACT INFECTION | 1/135 (0.7%) | |
| Injury, poisoning and procedural complications | ||
| LUNG CONTUSION | 1/135 (0.7%) | |
| TRAUMATIC SUBARACHNOID HEMATOMA | 1/135 (0.7%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| CANCER OF HEAD OF PANCREAS | 1/135 (0.7%) | |
| PROSTATE CANCER | 1/135 (0.7%) | |
| Nervous system disorders | ||
| CARDIOGENIC CEREBRAL OCCLUSION | 1/135 (0.7%) | |
| INTERNAL CAROTID ARTERY OBSTRUCTION | 1/135 (0.7%) | |
| INTERNAL CAROTID ARTERY STENOSIS | 1/135 (0.7%) | |
| SECONDARY HYDROCEPHALIC CONDITION | 1/135 (0.7%) | |
| Reproductive system and breast disorders | ||
| PROSTATIC HYPERTROPHY | 1/135 (0.7%) | |
| Vascular disorders | ||
| BLEEDING | 2/135 (1.5%) | |
Other (Not Including Serious) Adverse Events |
||
| Absorb GT1 BVS | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/135 (2.2%) | |
| Cardiac disorders | ||
| STABLE CORONARY DISEASE | 1/135 (0.7%) | |
| General disorders | ||
| STENT THROMBOSIS | 1/135 (0.7%) | |
| Nervous system disorders | ||
| BILATERAL MIDDLE CEREBRAL ARTERY STENOSIS | 1/135 (0.7%) | |
| Skin and subcutaneous tissue disorders | ||
| DRUG ERUPTION | 1/135 (0.7%) | |
| Surgical and medical procedures | ||
| TLR | 2/135 (1.5%) | |
| Vascular disorders | ||
| BLEEDING | 1/135 (0.7%) | |
Limitations/Caveats
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 | Hajime Kusano |
|---|---|
| Organization | Abbott medical device |
| Phone | +1 408-845-1626 |
| hajime.kusano@abbott.com |
- 16-310