This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.
St. Luke's Medical Center
Phoenix, Arizona, United States
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
Time frame: 3 Years
Secondary Outcome - Freedom From Stent Fracture
Determined by x-ray at 1, 2 and 3 years using the following classifications: Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration AND the following categories: Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine
Time frame: 1, 2 and 3 years
Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years
Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.
Time frame: 1 and 2 years
Secondary Outcome - Freedom From 36-month Amputation
Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.
Time frame: 3 Years
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Memorial Medical Center
Modesto, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Christiana Care Health Services
Newark, Delaware, United States
First Coast Cardiovascular Institute, P.A.
Jacksonville, Florida, United States
Augusta Vascular Center
Augusta, Georgia, United States
DuPage Medical Group
Downers Grove, Illinois, United States
Rockford Cardiovascular Associates
Rockford, Illinois, United States
Central Iowa Hospital Corporation
Des Moines, Iowa, United States
Cardiovascular Solutions, LLC
Shreveport, Louisiana, United States
...and 13 more locations
Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.
Time frame: 3 Years
Secondary Outcome - Number of Participants Free From Acute Death
Defined as the absence of all-cause mortality occurring within 30 days of the procedure.
Time frame: 30 days
Secondary Outcome - Number of Successfully Implanted Stents
Defined as the ability to deploy the stent as intended at the treatment site.
Time frame: At procedure
Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year
Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.
Time frame: 1 Year
Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year
Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9.
Time frame: 1 Year
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes
Time frame: 1 Year
Secondary Outcome - Number of Adverse Events
Number of Adverse Events in the study through 3 Years.
Time frame: 3 Years