Absolute Pro® MOMENTUM™

This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

Time frame: 0 to 365 days

Population: Intention-to-treat (ITT) population. This analysis represents those subjects who were event free at this time point.

Primary safety endpoint is freedom from MAE which is defined as a composite of: * Death due to all causes * Index limb major amputation (at or above the ankle) * Clinically-driven target lesion revascularization (TLR)

Time frame: 30 days

Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.

Time frame: 0 - 24 Hours Post Study Procedure

Population: ITT population.

Clinical success: Defined on a per patient basis, as the attainment of a final residual stenosis of \< 30% by core laboratory assessment 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.

Time frame: With in 2 days after index post procedure or at hospital discharge (before 1 month)

Population: ITT population, per subject analysis

Device success defined on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.

Time frame: With in 2 days of index post procedure

Population: ITT population, per device analysis.

Technical success: Device success plus attainment of final residual stenosis of \< 30%

Time frame: With in 2 days of index post procedure

Population: ITT population, per lesion analysis

A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. 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 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. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.

Time frame: Pre-Procedure

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI \> 1.3 was excluded from the analysis.

A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. 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 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. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.

Time frame: 12 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI \> 1.3 was excluded from the analysis.

A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. 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 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. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI \> 1.3 was excluded from the analysis.

A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. 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 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. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI \> 1.3 was excluded from the analysis.

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. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

Time frame: At 1 year

Population: ITT population, per subject analysis.

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. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

Time frame: At 1 month

Population: ITT population, per subject analysis.

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. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

Time frame: At 6 months

Population: ITT population, per subject analysis.

Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following: * Worsening Rutherford-Becker Clinical Category; * Change in ABI by \>0.15 and ABI ≤0.8

Time frame: At 6 months

Population: ITT population, per subject analysis.

Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following: * Worsening Rutherford-Becker Clinical Category; * Change in ABI by \>0.15 and ABI ≤0.8

Time frame: At 1 year

Population: ITT population, per subject analysis.

Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following: * Worsening Rutherford-Becker Clinical Category; * Change in ABI by \>0.15 and ABI ≤0.8

Time frame: At 1 month

Population: ITT population, per subject analysis.

Time frame: At 1 year

Population: ITT population, per subject analysis.

Time frame: At 6 months

Population: ITT population, per subject analysis.

Time frame: At 1 month

Population: ITT population, per subject analysis.

In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of \> 2.4 will be used to determine restenosis via duplex ultrasound.

Time frame: 1 month

Population: ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.

In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of \> 2.4 will be used to determine restenosis via duplex ultrasound.

Time frame: 12 months

Population: ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.

In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography.

Time frame: 12 months

Population: ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.

In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography.

Time frame: 1 month

Population: ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.

Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

Time frame: At 1 year

Population: ITT population, per subject analysis.

Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

Time frame: At 6 months

Population: ITT population, per subject analysis.

Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

Time frame: At 1 month

Population: ITT population, per subject analysis.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 180 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 379 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 365 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: At day 0 (on the day of index procedure)

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 30 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 30 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 365 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 180 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: 0 to 379 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

Time frame: At day 0 (on the day of index procedure)

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Primary Stent Patency defined as \< 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

Time frame: 0 to 180 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Primary Stent Patency defined as \< 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

Time frame: 0 to 379 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Primary Stent Patency defined as \< 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

Time frame: 0 to 365 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Primary Stent Patency defined as \< 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.

Time frame: 0 to 30 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

Time frame: 0 to 180 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

Time frame: 0 to 30 days

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Percent Diameter Stenosis: The value calculated as 100 \* (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.

Time frame: Pre-Procedure

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Percent Diameter Stenosis: The value calculated as 100 \* (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.

Time frame: Post-Procedure (≥ 1 day)

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Percent Diameter Stenosis: The value calculated as 100 \* (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.

Time frame: Post-Procedure (≥ 1 day)

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Time frame: Pre-procedure

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Time frame: 12 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. rm-Based Scores.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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.

Time frame: 12 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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.

Time frame: Pre-procedure

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Xrays were performed to evaluate stent integrity and to determine the presence of any stent fractures. Grade of fracture as follows: 0 - No stent fracture(s) identified 1. \- Single strut fracture only 2. \- Multiple strut fractures 3. \- Stent fracture with alignment 4. \- Fracture out of alignment (≥ 2 segments) 5. \- Spiral Fracture

Time frame: 12 months

Population: ITT population.

Stent occlusion was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.

Time frame: > 30 Days Post Study Procedure

Population: ITT population.

Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.

Time frame: > 24 Hours - 30 Days Post Study Procedure

Population: ITT population.

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.

Time frame: At 1 month

Population: ITT population, per subject analysis.

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.

Time frame: At 6 months

Population: ITT population, per subject analysis.

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.

Time frame: At 1 year

Population: ITT population, per subject analysis.

The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Time frame: At 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Time frame: At 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Time frame: At 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.

Time frame: 1 year

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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). 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.

Time frame: Pre-procedure

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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). 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.

Time frame: 12 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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). 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.

Time frame: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

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). 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.

Time frame: 6 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.