Trial Outcomes & Findings for ABSORB Clinical Investigation, Cohort B (NCT NCT00856856)

Results Overview

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

30 days

Results posted on

2019-02-07

Participant Flow

Total of 101 patients (intent to treat patient population \[ITT\]) were enrolled in the ABSORB Cohort B study at 12 clinical sites in Europe/Australia/New Zealand between March 19, 2009 and November 6, 2009. Only for assessing imaging outcomes at different follow-up periods, subjects were divided into Group 1 (n = 45) \& Group 2 (n = 56).

ITT population were assessed for all clinical endpoints. For imaging outcomes,Group 1 (n=45) patients were followed up at 180 days, 2 \& 5 years; while Group 2 (n=56) patients at 1, 3 \& 5 years. Therefore, data related to imaging outcomes are available only for Group 1 at 180 days, 2 \& 5 years timeframe \& only for Group 2 at 1, 3 \& 5 years timeframe

Participant milestones

Participant milestones
Measure	Absorb BVS Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Baseline STARTED	101
Baseline COMPLETED	101
Baseline NOT COMPLETED	0
30-day Clinical Follow-up STARTED	101
30-day Clinical Follow-up COMPLETED	101
30-day Clinical Follow-up NOT COMPLETED	0
180-day Clinical Follow-up STARTED	101
180-day Clinical Follow-up COMPLETED	101
180-day Clinical Follow-up NOT COMPLETED	0
270-day Clinical Follow-up STARTED	101
270-day Clinical Follow-up COMPLETED	101
270-day Clinical Follow-up NOT COMPLETED	0
1-year Clinical Follow-up STARTED	101
1-year Clinical Follow-up COMPLETED	101
1-year Clinical Follow-up NOT COMPLETED	0
2-year Clinical Follow-up STARTED	101
2-year Clinical Follow-up COMPLETED	100
2-year Clinical Follow-up NOT COMPLETED	1
3-year Clinical Follow-up STARTED	100
3-year Clinical Follow-up COMPLETED	100
3-year Clinical Follow-up NOT COMPLETED	0
4-year Clinical Follow-up STARTED	100
4-year Clinical Follow-up COMPLETED	99
4-year Clinical Follow-up NOT COMPLETED	1
5-year Clinical Follow-up STARTED	100
5-year Clinical Follow-up COMPLETED	100
5-year Clinical Follow-up NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Absorb BVS Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
2-year Clinical Follow-up Lost to Follow-up	1
4-year Clinical Follow-up Missed visit	1

Baseline Characteristics

ABSORB Clinical Investigation, Cohort B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Age, Continuous	62.3 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Region of Enrollment New Zealand	14 participants n=5 Participants
Region of Enrollment Netherlands	30 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants
Region of Enrollment Poland	13 participants n=5 Participants
Region of Enrollment Denmark	12 participants n=5 Participants
Region of Enrollment France	8 participants n=5 Participants
Region of Enrollment Australia	4 participants n=5 Participants
Region of Enrollment Switzerland	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	2.0 percentage of participants

PRIMARY outcome

Timeframe: 1 year

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	6.9 percentage of participants

PRIMARY outcome

Timeframe: 180 days

Population: In Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days	0.19 Millimeter Standard Deviation 0.18

PRIMARY outcome

Timeframe: 1 year

Population: In Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year	0.27 Millimeter Standard Deviation 0.32

SECONDARY outcome

Timeframe: On day 0 (the day of procedure)

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.

Outcome measures

Outcome measures
Measure	Absorb BVS n=102 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Clinical Device Success (Per Lesion)	100.0 percentage of lesions

SECONDARY outcome

Timeframe: On day 0 (the day of procedure)

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Clinical Procedure Success (Per Patient)	98.0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	5.0 percentage of participants

SECONDARY outcome

Timeframe: 270 days

Population: Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	5.0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	9.0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	10.0 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	10.1 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up. Intent-to-treat (ITT) population.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Major Adverse Cardiac Event (MACE)	11.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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 BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	2.0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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 BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	5.0 Percentage of participants

SECONDARY outcome

Timeframe: 270 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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 BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	5.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

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 BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	6.9 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

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 BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	11.0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

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 BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	13.0 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

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 BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	13.1 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year 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 BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Hierarchical Target Vessel Failure (TVF)	14.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	0 percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	2.0 Percentage of participants

SECONDARY outcome

Timeframe: 270 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	2.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	4.0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	6.0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	7.0 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	7.1 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	8.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	2.0 Percentage of participants

SECONDARY outcome

Timeframe: 270 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	2.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	4.0 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	8.0 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	10.0 Percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patient (Group 1) lost to follow-up at 4-year follow-up period.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	10.0 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	11.0 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Cardiac Death	0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Cardiac Death	0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Cardiac Death	0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Cardiac Death	0 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Outcome measures

Outcome measures
Measure	Absorb BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Cardiac Death	0 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Cardiac Death	0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Myocardial Infarction	2.0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Myocardial Infarction	3.0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Myocardial Infarction	3.0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Myocardial Infarction	3.0 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	Absorb BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Myocardial Infarction	3.0 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Myocardial Infarction	3.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Thrombosis	0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Outcome measures

Outcome measures
Measure	Absorb BVS n=101 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Thrombosis	0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Thrombosis	0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Thrombosis	0 percentage of participants

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Outcome measures

Outcome measures
Measure	Absorb BVS n=99 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Thrombosis	0 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

Outcome measures

Outcome measures
Measure	Absorb BVS n=100 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Thrombosis	0 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years	0.27 Millimeter Standard Deviation 0.19

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS n=51 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years	0.29 Millimeter Standard Deviation 0.43

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS n=63 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years	0.26 Millimeter Standard Deviation 0.42

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days	0.07 Millimeter Standard Deviation 0.27

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year	0.12 Millimeter Standard Deviation 0.29

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years	0.12 Millimeter Standard Deviation 0.36

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=44 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years	0.14 Millimeter Standard Deviation 0.31

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. In Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=58 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years	0.14 Millimeter Standard Deviation 0.43

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=41 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days	0.07 Millimeter Standard Deviation 0.30

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=55 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year	0.07 Millimeter Standard Deviation 0.27

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=37 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years	0.04 Millimeter Standard Deviation 0.25

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=49 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years	0.08 Millimeter Standard Deviation 0.37

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

Outcome measures

Outcome measures
Measure	Absorb BVS n=61 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years	0.11 Millimeter Standard Deviation 0.35

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Angiographic Binary Restenosis (ABR)	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Angiographic Binary Restenosis (ABR)	3.5 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Angiographic Binary Restenosis (ABR)	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=51 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Angiographic Binary Restenosis (ABR)	7.8 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=64 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Angiographic Binary Restenosis (ABR)	7.8 Percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Dissection at follow-up that was present post-procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Dissection	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Dissection at follow-up that was present post-procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Dissection	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Dissection at follow-up that was present post-procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Dissection	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Dissection at follow-up that was present post-procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Dissection	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Dissection at follow-up that was present post-procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Dissection	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Percent Diameter Stenosis (%DS)	19.21 percentage of diameter stenosis Standard Deviation 7.62

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=56 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Percent Diameter Stenosis (%DS)	21.35 percentage of diameter stenosis Standard Deviation 11.18

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Percent Diameter Stenosis (%DS)	20.94 percentage of diameter stenosis Standard Deviation 7.63

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=51 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Percent Diameter Stenosis (%DS)	23.16 percentage of diameter stenosis Standard Deviation 14.85

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Outcome measures

Outcome measures
Measure	Absorb BVS n=64 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
In-scaffold Percent Diameter Stenosis (%DS)	22.74 percentage of diameter stenosis Standard Deviation 13.94

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Aneurysm	2.4 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Aneurysm	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Aneurysm	2.6 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Aneurysm	2.08 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population.Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Aneurysm	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=42 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Thrombus	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Thrombus	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: Intent-to-treat (ITT) population.Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Thrombus	2.6 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Thrombus	2.08 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=48 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Thrombus	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Vasomotion function was assessed in reaction to nitrate administration.

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Vasomotion Analysis: In-scaffold Mean Luminal Diameter Pre-Nitro	2.49 Millimeter Standard Deviation 0.37
Vasomotion Analysis: In-scaffold Mean Luminal Diameter Post-Nitro	2.56 Millimeter Standard Deviation 0.35

SECONDARY outcome

Timeframe: 180 days

Population: Cohort B, Group 1. ITT population; Intravascular ultrasound (IVUS) analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Outcome measures

Outcome measures
Measure	Absorb BVS n=40 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Volume Obstruction (VO)	1.22 percent of scaffold volume Standard Deviation 1.99

SECONDARY outcome

Timeframe: 1 year

Population: Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Outcome measures

Outcome measures
Measure	Absorb BVS n=56 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Volume Obstruction (VO)	1.47 percent of scaffold volume Standard Deviation 3.08

SECONDARY outcome

Timeframe: 2 year

Population: Cohort B, Group 1. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Volume Obstruction (VO)	3.33 percent of scaffold volume Standard Deviation 3.99

SECONDARY outcome

Timeframe: 3 year

Population: Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

Outcome measures

Outcome measures
Measure	Absorb BVS n=46 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Volume Obstruction (VO)	4.19 percent of scaffold volume Standard Deviation 6.43

SECONDARY outcome

Timeframe: 180 days

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=43 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Incomplete Apposition	2.3 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=57 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Incomplete Apposition	3.5 Percentage of participants

SECONDARY outcome

Timeframe: 2 year

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=43 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Incomplete Apposition	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 3 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=49 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Persisting Incomplete Apposition	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 180 days

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=40 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Late Incomplete Apposition	7.5 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=56 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Late Incomplete Apposition	3.6 Percentage of participants

SECONDARY outcome

Timeframe: 2 year

Population: Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=38 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Late Incomplete Apposition	2.6 Percentage of participants

SECONDARY outcome

Timeframe: 3 year

Population: Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Outcome measures

Outcome measures
Measure	Absorb BVS n=43 Participants Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Late Incomplete Apposition	7.0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Optical coherence tomography (OCT) analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Reference Area	6.34 mm^2 Standard Deviation 2.30

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: OCT analysis,Cohort B Group1 , Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=27 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Reference Area	6.29 mm^2 Standard Deviation 2.13

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: OCT analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=40 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Reference Area	6.24 mm^2 Standard Deviation 1.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: OCT analysis,Cohort B (Group 1 and Group 2), Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=50 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Reference Area	6.13 mm^2 Standard Deviation 1.96

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Area	5.92 mm^2 Standard Deviation 1.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Area	6.00 mm^2 Standard Deviation 1.76

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Area	6.06 mm^2 Standard Deviation 1.70

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat (ITT) Population.OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Area	6.22 mm^2 Standard Deviation 1.84

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Area	4.29 mm^2 Standard Deviation 1.39

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Area	4.29 mm^2 Standard Deviation 1.48

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Area	4.45 mm^2 Standard Deviation 1.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Area	4.15 mm^2 Standard Deviation 1.69

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Stent Area	7.42 mm^2 Standard Deviation 1.22

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Scaffold Area	8.14 mm^2 Standard Deviation 1.88

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Scaffold Area	8.50 mm^2 Standard Deviation 1.93

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Stent Area	5.96 mm^2 Standard Deviation 1.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 year

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Scaffold Area	6.33 mm^2 Standard Deviation 1.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Scaffold Area	6.66 mm^2 Standard Deviation 1.67

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Luminal Volume	106.33 mm^3 Standard Deviation 31.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Luminal Volume	107.66 mm^3 Standard Deviation 34.79

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Luminal Volume	103.31 mm^3 Standard Deviation 30.86

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B Group 1 and Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Luminal Volume	106.36 mm^3 Standard Deviation 32.72

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Stent Volume	132.90 mm^3 Standard Deviation 21.64

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Volume	145.78 mm^3 Standard Deviation 38.28

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Scaffold Volume	145.07 mm^3 Standard Deviation 36.69

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Diameter	2.71 mm Standard Deviation 0.39

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Diameter	2.72 mm Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Diameter	2.74 mm Standard Deviation 0.39

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

It is measured during QCA by the Angiographic Core Lab.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Luminal Diameter	2.77 mm Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Diameter (MLD)	2.30 mm Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1 , Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Diameter	2.30 mm Standard Deviation 0.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Diameter	2.34 mm Standard Deviation 0.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Luminal Diameter	2.25 mm Standard Deviation 0.49

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Stent Diameter	3.06 mm Standard Deviation 0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Scaffold Diameter	3.19 mm Standard Deviation 0.38

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Scaffold Diameter	3.26 mm Standard Deviation 0.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Stent Diameter	2.74 mm Standard Deviation 0.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Scaffold Diameter	2.82 mm Standard Deviation 0.33

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Scaffold Diameter	2.89 mm Standard Deviation 0.37

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Strut Volume	3.02 mm^3 Standard Deviation 0.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Strut Volume	2.61 mm^3 Standard Deviation 0.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Strut Volume	3.28 mm^3 Standard Deviation 0.83

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts Per BVS	162.1 Number of Struts Standard Deviation 31.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts Per BVS	160.9 Number of Struts Standard Deviation 27.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts Per BVS	145.2 Number of Struts Standard Deviation 32.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts Per BVS	7.1 Number of Struts Standard Deviation 29.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
% of Covered Struts (150 µm)	96.86 Percent of Covered Struts Standard Deviation 2.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
% of Acutely Covered Struts	98.07 Percent of Covered Struts Standard Deviation 3.27

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
% of Acutely Covered Struts	97.90 Percent of Covered Struts Standard Deviation 2.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
% of Uncovered Struts (150 µm)	3.14 Percent of Uncovered Struts Standard Deviation 2.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
% of Uncovered Struts (150 µm)	1.93 Percent of Uncovered Struts Standard Deviation 3.27

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
% of Uncovered Struts (150 µm)	2.10 Percent of Uncovered Struts Standard Deviation 2.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts in Side Branch	0.1 Number of struts Standard Deviation 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts in Side Branch	0.2 Number of struts Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts in Side Branch	0.2 Number of struts Standard Deviation 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Number of Struts in Side Branch	0.0 Number of struts Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Area Classical	1.54 mm^2 Standard Deviation 0.76

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Area BVS (Neointimal Area)	1.38 mm^2 Standard Deviation 0.75

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Volume Classical	27.27 mm^3 Standard Deviation 13.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Volume BVS	24.40 mm^3 Standard Deviation 12.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Obstruction Volume Classical	21.61 Percent of Tissue Coverage Obstruction Standard Deviation 11.77

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Obstruction Volume BVS	19.40 Percent of Tissue Coverage Obstruction Standard Deviation 11.52

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Area Classical	2.13 mm^2 Standard Deviation 0.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Area BVS (Neointimal Area)	1.99 mm^2 Standard Deviation 0.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Volume Classical	38.12 mm^3 Standard Deviation 10.99

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Volume BVS	35.51 mm^3 Standard Deviation 10.87

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Obstruction Volume Classical	27.10 Percent of Tissue Coverage Obstruction Standard Deviation 8.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Obstruction Volume BVS	25.22 Percent of Tissue Coverage Obstruction Standard Deviation 7.91

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Area Classical	2.44 mm^2 Standard Deviation 0.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Area BVS (Neointimal Area)	2.25 mm^2 Standard Deviation 0.60

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Volume Classical	41.76 mm^3 Standard Deviation 11.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Volume BVS	38.47 mm^3 Standard Deviation 11.20

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Obstruction Volume Classical	29.36 Percent of Tissue Coverage Obstruction Standard Deviation 7.28

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Tissue Coverage Obstruction Volume BVS	27.01 Percent of Tissue Coverage Obstruction Standard Deviation 7.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Flow Area	5.90 mm^2 Standard Deviation 1.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Flow Area	4.28 mm^2 Standard Deviation 1.39

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Strut Core Area	0.17 mm^2 Standard Deviation 0.05

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=31 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Percent (%) Lumen Area Stenosis	28.70 Percentage of Lumen Area Stenosis Standard Deviation 12.05

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Flow Area	6.00 mm^2 Standard Deviation 1.76

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Flow Area	4.29 mm^2 Standard Deviation 1.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Strut Core Area	0.15 mm^2 Standard Deviation 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=28 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Percent (%) Lumen Area Stenosis	28.75 Percentage of Lumen Area Stenosis Standard Deviation 10.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Flow Area	6.06 mm^2 Standard Deviation 1.70

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Flow Area	4.45 mm^2 Standard Deviation 1.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Strut Core Area	0.19 mm^2 Standard Deviation 0.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=45 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Percent (%) Lumen Area Stenosis	28.01 Percentage of Lumen Area Stenosis Standard Deviation 13.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Mean Flow Area	6.21 mm^2 Standard Deviation 1.83

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Minimum Flow Area	4.15 mm^2 Standard Deviation 1.69

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Outcome measures

Outcome measures
Measure	Absorb BVS n=54 Target lesions Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Percent (%) Lumen Area Stenosis	34.32 Percentage of Lumen Area Stenosis Standard Deviation 16.21

Adverse Events

ABSORB Stent

Serious events: 56 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABSORB Stent n=101 participants at risk Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Cardiac disorders Angina pectoris	23.8% 24/101 • Number of events 40 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Atrial fibrillation	4.0% 4/101 • Number of events 4 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Atrial flutter	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Bradycardia	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Cardiac failure congestive	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Coronary artery stenosis	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Coronary artery thrombosis	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Myocardial infarction	3.0% 3/101 • Number of events 3 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Myocardial ischaemia	5.9% 6/101 • Number of events 6 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Palpitations	2.0% 2/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Tachycardia	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Eye disorders Cataract	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Gastrointestinal disorders Abdominal pain upper	2.0% 2/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Gastrointestinal disorders Crohn's disease	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Gastrointestinal disorders Gastric ulcer	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Gastrointestinal disorders Tooth disorder	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Adverse drug reaction	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Chest discomfort	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Chest pain	2.0% 2/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Influenza like illness	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Malaise	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Non-cardiac chest pain	2.0% 2/101 • Number of events 11 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Thrombosis in device	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Hepatobiliary disorders Cholecystitis acute	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Infections and infestations Bronchopneumonia	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Infections and infestations Gangrene	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Infections and infestations Lower respiratory tract infection	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Infections and infestations Pneumonia	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Infections and infestations Postoperative wound infection	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Injury, poisoning and procedural complications Forearm fracture	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Injury, poisoning and procedural complications Meniscus lesion	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Investigations Cardiac stress test abnormal	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Metabolism and nutrition disorders Dehydration	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Back pain	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.0% 3/101 • Number of events 3 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Osteoporosis	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 2/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Nervous system disorders Carotid artery disease	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Nervous system disorders Haemorrhagic stroke	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Nervous system disorders Ischaemic stroke	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Nervous system disorders Presyncope	2.0% 2/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Nervous system disorders Syncope	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Renal and urinary disorders Nephrolithiasis	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Renal and urinary disorders Renal failure	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Renal and urinary disorders Urinary incontinence	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 2/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Skin and subcutaneous tissue disorders Diabetic foot	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Skin and subcutaneous tissue disorders Skin ulcer	2.0% 2/101 • Number of events 3 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Vascular disorders Haematoma	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Vascular disorders Intermittent claudication	0.99% 1/101 • Number of events 2 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Vascular disorders Varicose vein	0.99% 1/101 • Number of events 1 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.

Other adverse events

Other adverse events
Measure	ABSORB Stent n=101 participants at risk Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Cardiac disorders Angina pectoris	43.6% 44/101 • Number of events 84 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Atrial fibrillation	5.9% 6/101 • Number of events 10 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Coronary artery dissection	9.9% 10/101 • Number of events 10 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Cardiac disorders Myocardial ischaemia	5.9% 6/101 • Number of events 6 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
General disorders Non-cardiac chest pain	17.8% 18/101 • Number of events 30 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 6/101 • Number of events 6 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.9% 9/101 • Number of events 11 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Vascular disorders Haematoma	7.9% 8/101 • Number of events 8 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Vascular disorders Hypertension	8.9% 9/101 • Number of events 10 • 5 years The data for adverse event reporting \& clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 \& 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 \& 5 years) and Group 2 (n = 56; followed for 1, 2 \& 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.

Additional Information

Susan Veldhof

Abbott Vascular International BVBA

Phone: 31653428610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60