Trial Outcomes & Findings for ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System (NCT NCT01468974)

Results Overview

Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

On Day 0 (From start of index procedure to end of index procedure)

Results posted on

2019-02-04

Participant Flow

A total of 35 subjects registered in this study were implanted with the ESPRIT BVS at 7 centers in 4 countries (Belgium, France, Germany and Austria) across Europe. First subject was registered in the ESPRIT I Clinical Investigation on December 20, 2011. The last subject was registered on August 28, 2012.

Participant milestones

Participant milestones
Measure	ESPRIT BVS Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
1 Month Follow-up STARTED	35
1 Month Follow-up COMPLETED	34
1 Month Follow-up NOT COMPLETED	1
6 Months Follow-up STARTED	34
6 Months Follow-up COMPLETED	34
6 Months Follow-up NOT COMPLETED	0
1 Year Follow-up STARTED	34
1 Year Follow-up COMPLETED	34
1 Year Follow-up NOT COMPLETED	0
2 Years Follow-up STARTED	34
2 Years Follow-up COMPLETED	32
2 Years Follow-up NOT COMPLETED	2
3 Years Follow-up STARTED	32
3 Years Follow-up COMPLETED	26
3 Years Follow-up NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Age, Continuous	65.3 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment Austria	4 participants n=5 Participants
Region of Enrollment Belgium	20 participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants
Region of Enrollment Germany	8 participants n=5 Participants

PRIMARY outcome

Timeframe: On Day 0 (From start of index procedure to end of index procedure)

Population: Intent-to-treat (ITT) population.

Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Device Success	100.0 percentage of devices

PRIMARY outcome

Timeframe: On Day 0 (From start of index procedure to end of index procedure)

Population: ITT population.

Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of \< 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Technical Success	97.1 percentage of target lesions

PRIMARY outcome

Timeframe: > or = 2 days after the index procedure

Population: ITT population.

Defined on a per subject basis, as the attainment of a final residual stenosis of \< 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications\* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated). \*Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Clinical Success	97.1 percentage of participants

SECONDARY outcome

Timeframe: 1 month

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

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.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Death	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

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.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Death	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

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.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Death	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

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.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Death	1 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

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.) -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Death	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Any Amputation of Treated Limb (Minor and Major)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Any Amputation of Treated Limb (Minor and Major)	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Any Amputation of Treated Limb (Minor and Major)	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Any Amputation of Treated Limb (Minor and Major)	0 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Any Amputation of Treated Limb (Minor and Major)	0 Participants

SECONDARY outcome

Timeframe: 0 to 30 days

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	35 Participants

SECONDARY outcome

Timeframe: 0 to 180 days

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	34 Participants

SECONDARY outcome

Timeframe: 0 to 365 days

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	34 Participants

SECONDARY outcome

Timeframe: 0 to 730 days

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	34 Participants

SECONDARY outcome

Timeframe: 0 to 1095 days

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated. A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	30 Participants

SECONDARY outcome

Timeframe: 0 to 1 month

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Scaffold Thrombosis	0 Participants

SECONDARY outcome

Timeframe: 1 month

Population: ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Scaffold Occlusion	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Scaffold Occlusion	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Scaffold Occlusion	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Scaffold Occlusion	1 Participants

SECONDARY outcome

Timeframe: 0 to 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Scaffold Occlusion	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Target Lesion Revascularization (TLR)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Target Lesion Revascularization (TLR)	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Target Lesion Revascularization (TLR)	3 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Target Lesion Revascularization (TLR)	4 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Target Lesion Revascularization (TLR)	4 Participants

SECONDARY outcome

Timeframe: 1 month

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

A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	3 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	3 Participants

SECONDARY outcome

Timeframe: 1 month

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

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ipsilateral Extremity Revascularization (IER)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ipsilateral Extremity Revascularization (IER)	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ipsilateral Extremity Revascularization (IER)	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ipsilateral Extremity Revascularization (IER)	3 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity. Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Ipsilateral Extremity Revascularization (IER)	3 Participants

SECONDARY outcome

Timeframe: 1 month

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

At the designated follow-up, intervention-free patency (\< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Primary Patency	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

At the designated follow-up, intervention-free patency (\< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Primary Patency	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

At the designated follow-up, intervention-free patency (\< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Primary Patency	7 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

At the designated follow-up, intervention-free patency (\< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Primary Patency	8 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

At the designated follow-up, intervention-free patency (\< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Primary Patency	9 Participants

SECONDARY outcome

Timeframe: 1 month

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 0	28 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 1	4 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 2	1 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 3	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 4	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 5	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 6	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 0	23 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 1	8 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 2	3 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 3	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 4	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 5	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 6	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 0	25 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 1	4 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 2	3 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 3	2 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 4	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 5	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 6	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=31 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 0	22 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 1	3 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 2	4 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 3	2 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 4	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 5	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 6	0 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=25 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 0	19 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 1	3 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 2	3 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 3	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 4	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 5	0 Participants
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb Category 6	0 Participants

SECONDARY outcome

Timeframe: At 1 month

Population: ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=30 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Ankle Brachial Index (ABI) for the Treated Limb	1.00 ratio Standard Deviation 0.11

SECONDARY outcome

Timeframe: At 6 months

Population: ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Ankle Brachial Index (ABI) for the Treated Limb	0.99 ratio Standard Deviation 0.13

SECONDARY outcome

Timeframe: At 1 year

Population: ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Ankle Brachial Index (ABI) for the Treated Limb	0.98 ratio Standard Deviation 0.15

SECONDARY outcome

Timeframe: At 2 years

Population: ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Ankle Brachial Index (ABI) for the Treated Limb	0.96 ratio Standard Deviation 0.16

SECONDARY outcome

Timeframe: At 3 years

Population: ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis. Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=23 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Ankle Brachial Index (ABI) for the Treated Limb	0.95 ratio Standard Deviation 0.13

SECONDARY outcome

Timeframe: At 1 month

Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=33 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Walking Impairment Questionnaire (WIQ) Scores Walking Distance Score	86.02 score on a scale Standard Deviation 24.58
Walking Impairment Questionnaire (WIQ) Scores Walking Speed Score	56.55 score on a scale Standard Deviation 21.99
Walking Impairment Questionnaire (WIQ) Scores Stair Climbing Score	84.22 score on a scale Standard Deviation 23.93

SECONDARY outcome

Timeframe: At 6 months

Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Walking Impairment Questionaire Scores Walking Distance Score	85.81 score on a scale Standard Deviation 24.66
Walking Impairment Questionaire Scores Walking Speed Score	52.79 score on a scale Standard Deviation 20.27
Walking Impairment Questionaire Scores Stair Climbing Score	81.25 score on a scale Standard Deviation 25.17

SECONDARY outcome

Timeframe: At 1 year

Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=34 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Walking Impairment Questionaire Scores Walking Distance Score	84.48 score on a scale Standard Deviation 29.86
Walking Impairment Questionaire Scores Walking Speed Score	52.69 score on a scale Standard Deviation 22.18
Walking Impairment Questionaire Scores Stair Climbing Score	87.50 score on a scale Standard Deviation 20.72

SECONDARY outcome

Timeframe: At 2 years

Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=31 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Walking Impairment Questionaire Scores Walking Distance Score	84.15 score on a scale Standard Deviation 25.70
Walking Impairment Questionaire Scores Walking Speed Score	50.93 score on a scale Standard Deviation 23.25
Walking Impairment Questionaire Scores Stair Climbing Score	83.60 score on a scale Standard Deviation 21.86

SECONDARY outcome

Timeframe: At 3 years

Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=25 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Walking Impairment Questionaire Scores Walking Distance Score	76.11 score on a scale Standard Deviation 25.86
Walking Impairment Questionaire Scores Walking Speed Score	56.74 score on a scale Standard Deviation 23.35
Walking Impairment Questionaire Scores Stair Climbing Score	75.50 score on a scale Standard Deviation 22.54

SECONDARY outcome

Timeframe: 1 month

Population: PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity (PSV)	154.6 cm/sec Standard Deviation 46.8

SECONDARY outcome

Timeframe: 6 months

Population: PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=30 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity (PSV)	151.5 cm/sec Standard Deviation 37.7

SECONDARY outcome

Timeframe: 1 year

Population: PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=30 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity (PSV)	161.5 cm/sec Standard Deviation 72.6

SECONDARY outcome

Timeframe: 2 years

Population: PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=26 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity (PSV)	162.7 cm/sec Standard Deviation 47.9

SECONDARY outcome

Timeframe: 3 years

Population: PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=17 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity (PSV)	172.5 cm/sec Standard Deviation 67.2

SECONDARY outcome

Timeframe: 1 month

Population: PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity Ratio (PSVR)	1.26 ratio Standard Deviation 0.30

SECONDARY outcome

Timeframe: 6 months

Population: PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=30 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity Ratio (PSVR)	1.35 ratio Standard Deviation 0.39

SECONDARY outcome

Timeframe: 1 year

Population: PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=29 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity Ratio (PSVR)	1.66 ratio Standard Deviation 1.16

SECONDARY outcome

Timeframe: 2 years

Population: PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=24 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-Scaffold Peak Systolic Velocity Ratio (PSVR)	1.56 ratio Standard Deviation 0.49

SECONDARY outcome

Timeframe: 3 years

Population: PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.

Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=15 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
In-scaffold Peak Systolic Velocity Ratio (PSVR)	1.66 ratio Standard Deviation 0.57

SECONDARY outcome

Timeframe: post-procedure

Percent diameter stenosis (%DS) value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA. * Reference Vessel Diameter (RVD) * Minimum Luminal Diameter(MLD)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=35 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Treated Site Percent Diameter Stenosis (%DS) In-Scaffold	9.21 Percent Diameter stenosis Standard Deviation 7.18
Treated Site Percent Diameter Stenosis (%DS) In-Segment	14.01 Percent Diameter stenosis Standard Deviation 8.25

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Percent diameter stenosis (%DS) value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA. * Reference Vessel Diameter (RVD) * Minimum Luminal Diameter(MLD)

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=28 Target lesions Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Treated Site Percent Diameter Stenosis (%DS) In-Scaffold	31.88 percent diameter stenosis Standard Deviation 26.06
Treated Site Percent Diameter Stenosis (%DS) In-Segment	35.24 percent diameter stenosis Standard Deviation 23.69

SECONDARY outcome

Timeframe: 12 months

Population: The analysis population included subjects who had available follow up data at that time frame.

Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up). The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab.

Outcome measures

Outcome measures
Measure	ESPRIT BVS n=28 Participants Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Treated Site Late Loss In-Scaffold	1.30 Millimeter Standard Deviation 1.53
Treated Site Late Loss In-Segment	1.23 Millimeter Standard Deviation 1.54

SECONDARY outcome

Timeframe: 1 year

Population: ITT Population. The analysis population included subjects who had available follow up data at that time frame.

Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA). Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only In-scaffold %DS ≥ 50% by Arteriogram Only