Trial Outcomes & Findings for Absolute Pro® MOMENTUM™ (NCT NCT01444378)

NCT ID: NCT01444378

Last Updated: 2017-06-06

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 141 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2017-06-06

Participant Flow

The first patient was registered in the MOMENTUM trial on November 2011. Enrollment in the trial was closed on November 2013. Based on the February 19, 2015, data extraction, 141 patients were registered in the MOMENTUM trial.at 32 US sites

Participant milestones

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Overall Study STARTED	141
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1
Overall Study Death	3
Overall Study Administrative Closure Of The Study	2
Overall Study Missed Visits	10

Baseline Characteristics

Absolute Pro® MOMENTUM™

Baseline characteristics by cohort

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Age, Continuous	67.3 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African Heritage	19 participants n=5 Participants
Race/Ethnicity, Customized Latino-Hispanic	3 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized White	120 participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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)

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Major Adverse Event (MAE) Death due to all causes	0.0 percentage of participants	—	—
Major Adverse Event (MAE) Index Limb Major Amputation (at or above the ankle	0.0 percentage of participants	—	—
Major Adverse Event (MAE) Clinically-driven TLR	0.0 percentage of participants	—	—

PRIMARY outcome

Timeframe: 0 to 365 days

Population: Intention-to-treat (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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Vessel Patency	60.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: With in 2 days of index post procedure

Population: ITT population, per device 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=146 Device Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Acute Success : Device Success	96.6 percentage of devices	—	—

SECONDARY outcome

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

Population: ITT population, per subject analysis

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=137 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Acute Success : Clinical Success	97.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: With in 2 days of index post procedure

Population: ITT population, per lesion analysis

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

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=137 Target Lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Acute Success : Technical Success	97.1 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Vessel Patency	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Vessel Patency	90.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=136 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Ankle Brachial Index (ABI) for the Treated Limb	0.75 Ratio Standard Deviation 0.19	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=110 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Ankle Brachial Index (ABI) for the Treated Limb	0.97 Ratio Standard Deviation 0.13	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=118 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Ankle Brachial Index (ABI) for the Treated Limb	0.92 Ratio Standard Deviation 0.18	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=106 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Ankle Brachial Index (ABI) for the Treated Limb	0.88 Ratio Standard Deviation 0.17	—	—

SECONDARY outcome

Timeframe: At 1 month

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

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Clinically-driven Target Lesion Revascularization (CD-TLR)	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Clinically-driven Target Lesion Revascularization (CD-TLR)	7.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Clinically-driven Target Lesion Revascularization (CD-TLR)	19.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Any Target Lesion Revascularization (TLR)	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: At 6 months

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Any Target Lesion Revascularization (TLR)	1.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Any Target Lesion Revascularization (TLR)	3.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Target Vessel Revascularization (TVR)	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Target Vessel Revascularization (TVR)	5.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: At 1 year

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Target Vessel Revascularization (TVR)	7.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: At 1 month

Population: ITT population, per subject analysis.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Death	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: At 6 months

Population: ITT population, per subject analysis.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Death	0.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: At 1 year

Population: ITT population, per subject analysis.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Death	2.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 0 to 30 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Stent Patency	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Stent Patency	90.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Stent Patency	60.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Stent Patency	53.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Any Ipsilateral Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Any Ipsilateral Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Any Ipsilateral Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Any Ipsilateral Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Any Ipsilateral Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: At 1 month

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Embolic Events in the Treated Limb (as Reported by Site)	0.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Embolic Events in the Treated Limb (as Reported by Site)	1.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Embolic Events in the Treated Limb (as Reported by Site)	1.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

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

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=136 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Rutherford-Becker Clinical Category for the Treated Limb Category 0	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 1	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 2	27.9 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 3	62.5 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 4	9.6 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 5	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 6	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=116 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Rutherford-Becker Clinical Category for the Treated Limb Category 0	56.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 1	24.1 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 2	18.1 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 3	1.7 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 4	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 5	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 6	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=116 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Rutherford-Becker Clinical Category for the Treated Limb Category 0	50.9 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 1	21.6 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 2	15.5 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 3	12.1 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 4	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 5	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 6	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=104 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Rutherford-Becker Clinical Category for the Treated Limb Category 0	52.9 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 2	19.2 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 3	4.8 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 4	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 5	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 6	0.0 percentage of participants	—	—
Rutherford-Becker Clinical Category for the Treated Limb Category 1	23.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=140 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score n=140 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score n=138 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Walking Impairment Questionnaire Scores	15.94 scores on a scale Standard Deviation 18.71	20.45 scores on a scale Standard Deviation 20.31	28.20 scores on a scale Standard Deviation 26.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=120 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score n=120 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score n=114 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Walking Impairment Questionnaire Scores	47.82 scores on a scale Standard Deviation 36.74	46.19 scores on a scale Standard Deviation 32.11	54.53 scores on a scale Standard Deviation 35.20

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=124 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score n=124 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score n=123 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Walking Impairment Questionnaire Scores	49.61 scores on a scale Standard Deviation 38.67	44.89 scores on a scale Standard Deviation 31.82	55.05 scores on a scale Standard Deviation 35.56

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score n=110 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Walking Impairment Questionnaire Scores	48.32 scores on a scale Standard Deviation 37.53	42.92 scores on a scale Standard Deviation 32.35	52.59 scores on a scale Standard Deviation 35.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=140 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Maximum Walking Distance 20 feet	3.6 percentage of participants	—	—
Maximum Walking Distance 50 feet	12.9 percentage of participants	—	—
Maximum Walking Distance 150 feet	21.4 percentage of participants	—	—
Maximum Walking Distance 300 feet	13.6 percentage of participants	—	—
Maximum Walking Distance 600 feet	12.1 percentage of participants	—	—
Maximum Walking Distance 900 feet	12.1 percentage of participants	—	—
Maximum Walking Distance 1500 feet	24.3 percentage of participants	—	—
Maximum Walking Distance 0 feet	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=120 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Maximum Walking Distance 0 feet	0.0 percentage of participants	—	—
Maximum Walking Distance 20 feet	1.7 percentage of participants	—	—
Maximum Walking Distance 50 feet	4.2 percentage of participants	—	—
Maximum Walking Distance 150 feet	4.2 percentage of participants	—	—
Maximum Walking Distance 300 feet	14.2 percentage of participants	—	—
Maximum Walking Distance 600 feet	10.0 percentage of participants	—	—
Maximum Walking Distance 900 feet	10.8 percentage of participants	—	—
Maximum Walking Distance 1500 feet	55.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=124 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Maximum Walking Distance 0 feet	0.8 percentage of participants	—	—
Maximum Walking Distance 20 feet	2.4 percentage of participants	—	—
Maximum Walking Distance 50 feet	6.5 percentage of participants	—	—
Maximum Walking Distance 150 feet	7.3 percentage of participants	—	—
Maximum Walking Distance 300 feet	8.1 percentage of participants	—	—
Maximum Walking Distance 600 feet	6.5 percentage of participants	—	—
Maximum Walking Distance 900 feet	7.3 percentage of participants	—	—
Maximum Walking Distance 1500 feet	61.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Maximum Walking Distance 0 feet	0.9 percentage of participants	—	—
Maximum Walking Distance 20 feet	0.9 percentage of participants	—	—
Maximum Walking Distance 50 feet	6.3 percentage of participants	—	—
Maximum Walking Distance 150 feet	6.3 percentage of participants	—	—
Maximum Walking Distance 300 feet	9.0 percentage of participants	—	—
Maximum Walking Distance 900 feet	6.3 percentage of participants	—	—
Maximum Walking Distance 1500 feet	62.2 percentage of participants	—	—
Maximum Walking Distance 600 feet	8.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

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

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=106 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Stent Integrity by X-ray 0 - No Fracture	95.3 percentage of participants	—	—
Stent Integrity by X-ray 1 - Single Strut	1.9 percentage of participants	—	—
Stent Integrity by X-ray 2 - Multiple Struts	2.8 percentage of participants	—	—
Stent Integrity by X-ray 3 - Stent Fracture w/Alignment	0.0 percentage of participants	—	—
Stent Integrity by X-ray 4 - Stent Fracture out of Alignment (2+ segments)	0.0 percentage of participants	—	—
Stent Integrity by X-ray 5 - Spiral Fracture	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=23 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Toe Brachial Index (TBI)	0.73 ratio Standard Deviation 0.19	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=18 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Toe Brachial Index (TBI)	0.70 ratio Standard Deviation 0.24	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=21 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Toe Brachial Index (TBI)	0.71 ratio Standard Deviation 0.22	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=114 Target lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)	142.8 cm/sec Standard Deviation 40.4	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=87 Target lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)	214.7 cm/sec Standard Deviation 105.0	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=113 Target lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)	1.13 cm/sec Standard Deviation 0.28	—	—

SECONDARY outcome

Timeframe: 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. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=85 Target lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)	1.98 cm/sec Standard Deviation 1.24	—	—

SECONDARY outcome

Timeframe: 0 - 24 Hours 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Acute Stent Thrombosis	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: > 24 Hours - 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Sub-Acute Stent Thrombosis	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: > 30 Days Post Study Procedure

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Stent Occlusion	10.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=137 Target lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
In-Segment Percent Diameter Stenosis (%DS)	79.02 Percent Diameter stenosis Standard Deviation 16.90	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=137 Target lesions Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
In-Segment Percent Diameter Stenosis (%DS)	15.18 Percent Diameter stenosis Standard Deviation 8.91	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=137 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
In-Stent Percent Diameter Stenosis (%DS)	4.10 Percent Diameter stenosis Standard Deviation 13.05	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Ipsilateral Major Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Ipsilateral Major Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Ipsilateral Major Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Ipsilateral Major Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Freedom From Ipsilateral Major Amputation	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=115 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Physical Functioning (PF)	41.53 score on a scale Standard Deviation 11.83	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Physical Functioning (PF)	41.70 score on a scale Standard Deviation 12.06	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Physical Functioning (PF)	38.28 score on a scale Standard Deviation 11.85	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=116 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Role Physical (RP)	43.83 score on a scale Standard Deviation 10.26	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Role Physical (RP)	42.94 score on a scale Standard Deviation 11.86	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=109 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Role Physical (RP)	41.07 score on a scale Standard Deviation 11.50	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=116 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Bodily Pain (BP)	43.83 score on a scale Standard Deviation 12.09	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Bodily Pain (BP)	41.52 score on a scale Standard Deviation 13.15	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=109 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Bodily Pain (BP)	42.30 score on a scale Standard Deviation 12.06	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=117 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : General Health (GH)	38.49 score on a scale Standard Deviation 9.24	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : General Health (GH)	39.72 score on a scale Standard Deviation 10.20	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : General Health (GH)	39.65 score on a scale Standard Deviation 9.50	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=117 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Vitality (VT)	46.89 score on a scale Standard Deviation 11.49	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Vitality (VT)	47.83 score on a scale Standard Deviation 11.14	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Vitality (VT)	46.57 score on a scale Standard Deviation 11.49	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=117 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Social Functioning (SF)	49.40 score on a scale Standard Deviation 9.84	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Social Functioning (SF)	47.47 score on a scale Standard Deviation 12.80	—	—

SECONDARY outcome

Timeframe: 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.

rm-Based Scores.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Social Functioning (SF)	48.74 score on a scale Standard Deviation 10.69	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=117 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Role Emotional (RE)	46.86 score on a scale Standard Deviation 11.94	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=119 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Role Emotional (RE)	45.79 score on a scale Standard Deviation 12.22	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=109 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Role Emotional (RE)	45.97 score on a scale Standard Deviation 12.11	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=117 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Mental Health (MH)	50.94 score on a scale Standard Deviation 10.42	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=121 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Mental Health (MH)	50.44 score on a scale Standard Deviation 10.79	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Mental Health (MH)	50.10 score on a scale Standard Deviation 11.18	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=114 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Physical Component Summary (PCS)	39.82 score on a scale Standard Deviation 9.99	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=119 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Physical Component Summary (PCS)	39.71 score on a scale Standard Deviation 11.11	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=109 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Physical Component Summary (PCS)	37.51 score on a scale Standard Deviation 10.75	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=114 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Mental Component Summary (MCS)	52.03 score on a scale Standard Deviation 9.99	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=119 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Mental Component Summary (MCS)	51.08 score on a scale Standard Deviation 10.36	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=109 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Quality of Life Measures : Mental Component Summary (MCS)	51.71 score on a scale Standard Deviation 10.38	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=120 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Vascular Quality of Life (VascuQol) Total Scores	5.62 score on a scale Standard Deviation 1.37	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=124 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Vascular Quality of Life (VascuQol) Total Scores	5.38 score on a scale Standard Deviation 1.55	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=111 Participants Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Walking Speed Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Stair Climbing Score Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Vascular Quality of Life (VascuQol) Total Scores	5.41 score on a scale Standard Deviation 1.36	—	—

Adverse Events

Absolute Pro® and Pro LL® Peripheral Stent Systems

Serious events: 81 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 participants at risk Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Injury, poisoning and procedural complications Hematoma	0.71% 1/141 • 12 months (365 days)
Immune system disorders Allergic Reaction To Diabetic Meds	0.71% 1/141 • 12 months (365 days)
Immune system disorders other	1.4% 2/141 • 12 months (365 days)
Immune system disorders Rash	0.71% 1/141 • 12 months (365 days)
Blood and lymphatic system disorders Bleeding	0.71% 1/141 • 12 months (365 days)
Blood and lymphatic system disorders Hematoma	1.4% 2/141 • 12 months (365 days)
Blood and lymphatic system disorders Abnormal Lab Test	0.71% 1/141 • 12 months (365 days)
Blood and lymphatic system disorders Anemia	2.1% 3/141 • 12 months (365 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant	2.8% 4/141 • 12 months (365 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Disorder	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Angina	2.8% 4/141 • 12 months (365 days)
Cardiac disorders Arrhythmia (Includes Brady And Tachy)	5.7% 8/141 • 12 months (365 days)
Cardiac disorders CAD - Coronary stenosis	1.4% 2/141 • 12 months (365 days)
Cardiac disorders Cardiac Arrest	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Congestive Heart Failure	2.8% 4/141 • 12 months (365 days)
Cardiac disorders Hypertension	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Myocardial Infarction - Non Q wave	1.4% 2/141 • 12 months (365 days)
Cardiac disorders Myocardial Infarction - Unknown	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Myocardial Infarction ST Elevated	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Other	7.1% 10/141 • 12 months (365 days)
Cardiac disorders Pain	7.1% 10/141 • 12 months (365 days)
Cardiac disorders Surgery/Intervention Procedure	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Syncope	0.71% 1/141 • 12 months (365 days)
Cardiac disorders	0.71% 1/141 • 12 months (365 days)
Cardiac disorders Ventricular Dysfunction	0.71% 1/141 • 12 months (365 days)
Gastrointestinal disorders Cholecystitis	0.71% 1/141 • 12 months (365 days)
Gastrointestinal disorders Colitis	0.71% 1/141 • 12 months (365 days)
Gastrointestinal disorders GI Bleed	0.71% 1/141 • 12 months (365 days)
Gastrointestinal disorders Other	1.4% 2/141 • 12 months (365 days)
Gastrointestinal disorders Pain	0.71% 1/141 • 12 months (365 days)
Renal and urinary disorders Kidney Damage Due To Other	0.71% 1/141 • 12 months (365 days)
Renal and urinary disorders Pyelonephritis	0.71% 1/141 • 12 months (365 days)
Renal and urinary disorders Renal Failure	0.71% 1/141 • 12 months (365 days)
Renal and urinary disorders Renal Insufficiency	0.71% 1/141 • 12 months (365 days)
Renal and urinary disorders Urinary Tract Infection	0.71% 1/141 • 12 months (365 days)
Infections and infestations Abscess	0.71% 1/141 • 12 months (365 days)
Infections and infestations Bronchitis	0.71% 1/141 • 12 months (365 days)
Infections and infestations Cellulitis	0.71% 1/141 • 12 months (365 days)
Infections and infestations Pancreatic Disorder	0.71% 1/141 • 12 months (365 days)
Infections and infestations Pneumonia	2.8% 4/141 • 12 months (365 days)
Infections and infestations Sepsis	1.4% 2/141 • 12 months (365 days)
Infections and infestations Urinary Tract Infection	0.71% 1/141 • 12 months (365 days)
Infections and infestations Wound Complication Or Wound Infection	1.4% 2/141 • 12 months (365 days)
Metabolism and nutrition disorders Encephalopathy	0.71% 1/141 • 12 months (365 days)
Metabolism and nutrition disorders Hyperglycemia	1.4% 2/141 • 12 months (365 days)
Metabolism and nutrition disorders Hyperkalemia	0.71% 1/141 • 12 months (365 days)
Metabolism and nutrition disorders Hyponatremia	0.71% 1/141 • 12 months (365 days)
Metabolism and nutrition disorders Other	0.71% 1/141 • 12 months (365 days)
Investigations Abnormal Lab Test	0.71% 1/141 • 12 months (365 days)
Investigations Other	1.4% 2/141 • 12 months (365 days)
Musculoskeletal and connective tissue disorders Arthritis	0.71% 1/141 • 12 months (365 days)
Musculoskeletal and connective tissue disorders Other	0.71% 1/141 • 12 months (365 days)
Musculoskeletal and connective tissue disorders Surgery/Intervention Procedure	1.4% 2/141 • 12 months (365 days)
Musculoskeletal and connective tissue disorders Trauma	0.71% 1/141 • 12 months (365 days)
Nervous system disorders Depression	0.71% 1/141 • 12 months (365 days)
Nervous system disorders Headache	0.71% 1/141 • 12 months (365 days)
Nervous system disorders Ischemic Encephalopathy	0.71% 1/141 • 12 months (365 days)
Nervous system disorders Mental Status Change	2.8% 4/141 • 12 months (365 days)
Nervous system disorders Other	0.71% 1/141 • 12 months (365 days)
Surgical and medical procedures Edema (Non Pulmonary)	0.71% 1/141 • 12 months (365 days)
Surgical and medical procedures Pseudoaneurysm	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Asbestosis	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Bronchitis	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders COPD	2.1% 3/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Chest Congestion	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Dyspnea	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Embolism	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Lung Mass	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Malignant	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.71% 1/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Pneumonia	2.1% 3/141 • 12 months (365 days)
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.4% 2/141 • 12 months (365 days)
Nervous system disorders Ischemic Stroke	0.71% 1/141 • 12 months (365 days)
Nervous system disorders	2.8% 4/141 • 12 months (365 days)
Vascular disorders Claudication	5.7% 8/141 • 12 months (365 days)
Vascular disorders Embolism	0.71% 1/141 • 12 months (365 days)
Vascular disorders Hematoma	1.4% 2/141 • 12 months (365 days)
Vascular disorders Ischemia	0.71% 1/141 • 12 months (365 days)
Vascular disorders Occlusion	0.71% 1/141 • 12 months (365 days)
Vascular disorders PAD	0.71% 1/141 • 12 months (365 days)
Vascular disorders PVD	6.4% 9/141 • 12 months (365 days)
Vascular disorders Pseudoaneurysm	2.1% 3/141 • 12 months (365 days)
Vascular disorders Pulmonary Emboli	0.71% 1/141 • 12 months (365 days)
Vascular disorders Pulmonary Embolism	0.71% 1/141 • 12 months (365 days)
Vascular disorders Renal Artery Disease	0.71% 1/141 • 12 months (365 days)
Vascular disorders Restenosis	13.5% 19/141 • 12 months (365 days)
Vascular disorders Stenosis	2.1% 3/141 • 12 months (365 days)

Other adverse events

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n=141 participants at risk Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
Cardiac disorders Arrhythmia (Includes Brady And Tachy)	8.5% 12/141 • 12 months (365 days)
General disorders Pain	9.2% 13/141 • 12 months (365 days)
Musculoskeletal and connective tissue disorders Pain	10.6% 15/141 • 12 months (365 days)
Vascular disorders Claudication	12.1% 17/141 • 12 months (365 days)
Vascular disorders Peripheral vascular diseases (PVD)	12.1% 17/141 • 12 months (365 days)
Vascular disorders Restenosis	17.7% 25/141 • 12 months (365 days)

Additional Information

Robert McGreevy

Abbott Vascular

Phone: 408-845-3932

Email: Robert.mcgreevy@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60