This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
287
Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.
Primary Patency
Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
Time frame: 1 Year
Major Adverse Events
Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)
Time frame: 30 Days
Single-Stent Primary Patency
Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.
Time frame: 1 Year
Single-Stent Major Adverse Events
MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.
Time frame: 30 Days
Major Adverse Events
MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.
Time frame: 1 Year
Stent Fracture Rate
Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.
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Time frame: 1, 2 and 3 Years
Number of Participants With Decline in Rutherford Clinical Category
Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.
Time frame: 30 days
Improvement in Rutherford Clinical Category
Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.
Time frame: 1 year
Increase in Ankle-Brachial Index From Baseline to 1 Year
Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9.
Time frame: 1 Year
Assisted Primary Patency
Assisted primary patency at 1 year was defined as PSV ratio \< 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.
Time frame: 1 Year
Secondary Patency
Secondary patency was defined as PSV ratio \< 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Time frame: 1 Year
Absolute Claudication Distance Improvement
Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.
Time frame: 1 Year
Walking Improvement
Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.
Time frame: 1 Year
Duplex Ultrasound ≤ 2.4 Primary Patency
Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Time frame: 1 Year