Trial Outcomes & Findings for Absorb GT1 Japan PMS (NCT NCT03409731)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

135 participants

Primary outcome timeframe

Day 0

Results posted on

2024-08-06

Participant Flow

This surveillance planned to consecutively enroll two thousand (2,000) patients. However, in September 2017, Abbott Vascular decided to stop selling the Absorb GT1 system globally, as result of low commercial sales uptake compared to the prediction. Surveillance sites could continue to use the device and register patients until December 15, 2017. As a result, 135 patients were enrolled (treatment with Absorb GT1 attempted, i.e., ITT) by December 11, 2017.

Participant milestones

Participant milestones
Measure	Absorb GT1 BVS Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Study STARTED	135
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Absorb GT1 BVS Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Study Withdrawal by Subject	17
Overall Study Death	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absorb GT1 BVS n=135 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Age, Continuous	64.0 years STANDARD_DEVIATION 10.9 • n=5 Participants • 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
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	135 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	135 Participants n=5 Participants
Region of Enrollment Japan	135 participants n=5 Participants
Diabetes Mellitus	53 Participants n=5 Participants
Dyslipidemia	84 Participants n=5 Participants
Hypertension	93 Participants n=5 Participants
Renal Failure	5 Participants n=5 Participants
Prior Coronary Intervention	35 Participants n=5 Participants
Previous Myocardial Infarction (MI)	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Acute Scaffold Thrombosis (ST) Definite	0 participants
Number of Participants With Acute Scaffold Thrombosis (ST) Probable	0 participants
Number of Participants With Acute Scaffold Thrombosis (ST) Definite/Probable	0 participants

PRIMARY outcome

Timeframe: >1 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Sub Acute Scaffold Thrombosis (ST) Definite	0 participants
Number of Participants With Sub Acute Scaffold Thrombosis (ST) Probable	0 participants
Number of Participants With Sub Acute Scaffold Thrombosis (ST) Definite/Probable	0 participants

PRIMARY outcome

Timeframe: 31 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Late Scaffold Thrombosis (ST) Definite	0 participants
Number of Participants With Late Scaffold Thrombosis (ST) Probable	0 participants
Number of Participants With Late Scaffold Thrombosis (ST) Definite/Probable	0 participants

PRIMARY outcome

Timeframe: 31 to 365 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Late Scaffold Thrombosis (ST) Definite	0 participants
Number of Participants With Late Scaffold Thrombosis (ST) Probable	0 participants
Number of Participants With Late Scaffold Thrombosis (ST) Definite/Probable	0 participants

PRIMARY outcome

Timeframe: 366 to 730 days

Population: 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

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=130 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Very Late Scaffold Thrombosis (ST) Definite	0 Participants
Number of Participants With Very Late Scaffold Thrombosis (ST) Probable	0 Participants
Number of Participants With Very Late Scaffold Thrombosis (ST) Definite/Probable	0 Participants

PRIMARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Overall Scaffold Thrombosis (ST) Definite	0 Participants
Number of Participants With Overall Scaffold Thrombosis (ST) Probable	0 Participants
Number of Participants With Overall Scaffold Thrombosis (ST) Definite/Probable	0 Participants

PRIMARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cumulative Scaffold Thrombosis Definite	0 participants
Number of Participants With Cumulative Scaffold Thrombosis Probable	0 participants
Number of Participants With Cumulative Scaffold Thrombosis Definite/Probable	0 participants

PRIMARY outcome

Timeframe: 0 to 730 days

Population: 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

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cumulative Scaffold Thrombosis Definite	0 Participants
Number of Participants With Cumulative Scaffold Thrombosis Probable	0 Participants
Number of Participants With Cumulative Scaffold Thrombosis Definite/Probable	0 Participants

PRIMARY outcome

Timeframe: During index procedure, "54.8 ± 27.6 min"

Population: Full Analysis Set (phase 1 participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Exclusion of Very Small Vessels < 2.25 mm	18 participants
Number of Participants With Exclusion of Very Small Vessels ≥ 2.25 mm - < 2.5 mm	26 participants
Number of Participants With Exclusion of Very Small Vessels ≥ 2.5 mm - ≤ 3.5 mm	91 participants
Number of Participants With Exclusion of Very Small Vessels > 3.5 mm	4 participants

PRIMARY outcome

Timeframe: During index procedure, "54.8 ± 27.6 min"

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=135 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging	5 Participants

PRIMARY outcome

Timeframe: During index procedure, "54.8 ± 27.6 min"

Population: Full Analysis Set (all participants with Absorb GT1)

Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=135 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Composite of Device Deficiencies Lesion/implant failure	0 Participants
Number of Participants With Composite of Device Deficiencies Delivery difficulty (finally delivered)	6 Participants
Number of Participants With Composite of Device Deficiencies Re-crossing failure	1 Participants
Number of Participants With Composite of Device Deficiencies Re-crossing difficulty	0 Participants
Number of Participants With Composite of Device Deficiencies Post-dilatation balloon+OCT/IVUS	11 Participants
Number of Participants With Composite of Device Deficiencies IFU not included	1 Participants
Number of Participants With Composite of Device Deficiencies Major Strut Malapposition	1 Participants
Number of Participants With Composite of Device Deficiencies Strut Fracture within 6 months	1 Participants

PRIMARY outcome

Timeframe: 731 - 1095 days

Population: Full Analysis Set (all participants with Absorb GT1)

Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), 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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=127 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Late Scaffold Thrombosis (ST) Probable	0 Participants
Number of Participants With Late Scaffold Thrombosis (ST) Definite/Probable	0 Participants
Number of Participants With Late Scaffold Thrombosis (ST) Definite	0 Participants

PRIMARY outcome

Timeframe: 0 - 1095 days

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=128 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cumulative Scaffold Thrombosis Definite	0 Participants
Number of Participants With Cumulative Scaffold Thrombosis Probable	0 Participants
Number of Participants With Cumulative Scaffold Thrombosis Definite/Probable	0 Participants

PRIMARY outcome

Timeframe: 1096 - 1460 days

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=120 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Very Late Scaffold Thrombosis (ST) Definite	0 Participants
Number of Participants With Very Late Scaffold Thrombosis (ST) Probable	0 Participants
Number of Participants With Very Late Scaffold Thrombosis (ST) Definite/Probable	0 Participants

PRIMARY outcome

Timeframe: 0 - 1460 days

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=122 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cumulative Scaffold Thrombosis Definite	0 Participants
Number of Participants With Cumulative Scaffold Thrombosis Probable	0 Participants
Number of Participants With Cumulative Scaffold Thrombosis Definite/Probable	0 Participants

PRIMARY outcome

Timeframe: 0 - 1825 days

Population: Full Analysis Set (all participants with Absorb GT1)

Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), 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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=116 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cumulative Scaffold Thrombosis Definite	0 participants
Number of Participants With Cumulative Scaffold Thrombosis Probable	0 participants
Number of Participants With Cumulative Scaffold Thrombosis Definite/Probable	0 participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	2 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	3 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	4 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Coronary Revascularization	1 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Coronary Revascularization	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Coronary Revascularization	3 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Coronary Revascularization	9 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	1 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	3 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	11 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 Year

Population: Full Analysis Set (all participants with Absorb GT1)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	4 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	0 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	3 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	3 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 90 days

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 1 year

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=134 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	0 Participants

SECONDARY outcome

Timeframe: 0 to 2 years

Population: 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

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=131 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	1 Participants

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology ACC/AHA Type B2/C	51.8 percentage of lesions
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology Severe/Moderate Calcification	11.5 percentage of lesions
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology Eccentric	27.3 percentage of lesions
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology Total Occlusion	0.0 percentage of lesions

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesion Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 0	0.00 percentage of TIMI flow
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 1	0.72 percentage of TIMI flow
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 2	2.16 percentage of TIMI flow
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 3	97.12 percentage of TIMI flow

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

Lesion Length (can be measured after successful post-dilatation)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Lesion Length	13.84 mm Standard Deviation 4.74

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

Proximal RVD (can be measured after successful post-dilatation)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)	3.15 mm Standard Deviation 0.49

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

Distal RVD (can be measured after successful post-dilatation)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Distal RVD	2.95 mm Standard Deviation 0.39

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)	1.00 mm Standard Deviation 0.30

SECONDARY outcome

Timeframe: Pre-procedure

Population: Full Analysis Set (all participants with Absorb GT1)

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).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=135 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)	63.1 percentage of diameter Standard Deviation 9.5

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesion Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 0	0.00 percentage of TIMI flow
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 1	0.72 percentage of TIMI flow
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 2	1.44 percentage of TIMI flow
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow 3	97.84 percentage of TIMI flow

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)	2.30 mm Standard Deviation 0.38

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )	18.4 percentage of diameter Standard Deviation 6.3

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )	1.29 mm Standard Deviation 0.44

SECONDARY outcome

Timeframe: Pre-procedure (or after pre-dilatation)

Population: 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

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) Proximal	8.04 mm^2 Standard Deviation 2.51
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) Distal	6.29 mm^2 Standard Deviation 2.30

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) Proximal	8.21 mm^2 Standard Deviation 2.47
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal) Distal	6.54 mm^2 Standard Deviation 2.21

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area	6.86 mm^2 Standard Deviation 1.77

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition	1.89 Percentage of lesions Standard Deviation 3.63

SECONDARY outcome

Timeframe: Post-procedure (average procedure time of "54.8 ± 27.6 min")

Population: Full Analysis Set (all participants with Absorb GT1)

Strut fracture will be measured as either number or percentage post-procedure

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=139 Lesions Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture Yes	1 Lesions
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture No	138 Lesions

SECONDARY outcome

Timeframe: 3 years

Population: 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

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	3 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	2 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	4 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	7 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Coronary Revascularization	12 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	16 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	8 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	6 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=129 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	3 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	4 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	2 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	6 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	11 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Coronary Revascularization	16 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	22 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	11 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	7 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	6 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=124 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	4 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)	4 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

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)

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Myocardial Infarction (MI)	2 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Lesion Revascularization (TLR)	6 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With All Target Vessel Revascularization (TVR)	11 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Death/MI/All Revascularization (DMR)	23 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Target Vessel Failure (TVF)	11 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Major Adverse Cardiac Event (MACE)	7 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	6 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Full Analysis Set (all participants with Absorb GT1)

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.

Outcome measures

Outcome measures
Measure	Absorb GT1 BVS n=118 Participants Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Number of Participants With Cardiac Death/Myocardial Infarction (MI)	4 Participants

Adverse Events

Absorb GT1 BVS

Serious events: 43 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Absorb GT1 BVS n=135 participants at risk Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Cardiac disorders Angina pectoris	10.4% 14/135 • 5 Years
Cardiac disorders Angina, unstable	1.5% 2/135 • 5 Years
Cardiac disorders Aortic valve stenosis	0.74% 1/135 • 5 Years
Cardiac disorders Atrial fibrillation	0.74% 1/135 • 5 Years
Cardiac disorders Coronary artery disease	9.6% 13/135 • 5 Years
Cardiac disorders Myocardial infarction	1.5% 2/135 • 5 Years
Ear and labyrinth disorders Sudden hearing loss	0.74% 1/135 • 5 Years
Ear and labyrinth disorders Vertigo	0.74% 1/135 • 5 Years
Eye disorders Cataract	1.5% 2/135 • 5 Years
Gastrointestinal disorders Colitis ischaemic	1.5% 2/135 • 5 Years
Gastrointestinal disorders Colonic polyp	2.2% 3/135 • 5 Years
Gastrointestinal disorders Gastrointestinal inflammation	0.74% 1/135 • 5 Years
General disorders Sudden death	0.74% 1/135 • 5 Years
Hepatobiliary disorders Biliary colic	0.74% 1/135 • 5 Years
Hepatobiliary disorders Cholecystitis	1.5% 2/135 • 5 Years
Hepatobiliary disorders Cholecystitis acute	0.74% 1/135 • 5 Years
Infections and infestations Abdominal infection	0.74% 1/135 • 5 Years
Infections and infestations Infection	0.74% 1/135 • 5 Years
Infections and infestations Pneumonia	1.5% 2/135 • 5 Years
Infections and infestations Urinary tract infection	0.74% 1/135 • 5 Years
Infections and infestations Viral infection	0.74% 1/135 • 5 Years
Injury, poisoning and procedural complications Coronary artery restenosis	1.5% 2/135 • 5 Years
Injury, poisoning and procedural complications Femur fracture	0.74% 1/135 • 5 Years
Injury, poisoning and procedural complications In-stent coronary artery restenosis	1.5% 2/135 • 5 Years
Injury, poisoning and procedural complications Pelvic fracture	0.74% 1/135 • 5 Years
Injury, poisoning and procedural complications Subdural haematoma	0.74% 1/135 • 5 Years
Injury, poisoning and procedural complications Traumatic haematoma	0.74% 1/135 • 5 Years
Injury, poisoning and procedural complications Traumatic lung injury	0.74% 1/135 • 5 Years
Investigations Hepatic Enzyme Increased	0.74% 1/135 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.74% 1/135 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.74% 1/135 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.74% 1/135 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.74% 1/135 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.74% 1/135 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.74% 1/135 • 5 Years
Nervous system disorders Carotid artery stenosis	1.5% 2/135 • 5 Years
Nervous system disorders Cerebral artery occlusion	0.74% 1/135 • 5 Years
Nervous system disorders Hydrocephalus	0.74% 1/135 • 5 Years
Reproductive system and breast disorders Benign prostatic hyperplasia	0.74% 1/135 • 5 Years
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.74% 1/135 • 5 Years
Skin and subcutaneous tissue disorders Dermal cyst	0.74% 1/135 • 5 Years
Surgical and medical procedures Knee arthroplasty	1.5% 2/135 • 5 Years
Vascular disorders Aortic aneurysm	0.74% 1/135 • 5 Years
Vascular disorders Haemorrhage	3.7% 5/135 • 5 Years
Vascular disorders Subclavian artery stenosis	0.74% 1/135 • 5 Years
Congenital, familial and genetic disorders Phimosis	0.74% 1/135 • 5 Years

Other adverse events

Other adverse events
Measure	Absorb GT1 BVS n=135 participants at risk Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Cardiac disorders Coronary artery disease	0.74% 1/135 • 5 Years
General disorders Thrombosis in Device	0.74% 1/135 • 5 Years
Nervous system disorders Cerebral artery stenosis	0.74% 1/135 • 5 Years
Skin and subcutaneous tissue disorders Dermal Eruption	0.74% 1/135 • 5 Years
Surgical and medical procedures Coronary Revascularization	0.74% 1/135 • 5 Years
Vascular disorders Haemorrhage	4.4% 6/135 • 5 Years

Additional Information

Hajime Kusano

Abbott medical device

Phone: +1 408-845-1626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60