EverFlex Post Approval Study
- Conditions
- Peripheral Arterial DiseaseLower Extremity Arterial Disease
- Interventions
- Device: EverFlex™ Self-Expanding Peripheral Stent System
- Registration Number
- NCT01680835
- Lead Sponsor
- Medtronic Endovascular
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study cohort EverFlex™ Self-Expanding Peripheral Stent System All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.
- Primary Outcome Measures
Name Time Method Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization 3 Years 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.
- Secondary Outcome Measures
Name Time Method Secondary Outcome - Number of Participants Free From Acute Death 30 days Defined as the absence of all-cause mortality occurring within 30 days of the procedure.
Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year 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.
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year 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 outcomesSecondary Outcome - Number of Successfully Implanted Stents At procedure Defined as the ability to deploy the stent as intended at the treatment site.
Secondary Outcome - Freedom From Stent Fracture 1, 2 and 3 years 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 determineSecondary Outcome - Freedom From 36-month Amputation 3 Years 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.
Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years 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.
Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization 3 Years 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.
Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year 1 Year Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.
Secondary Outcome - Number of Adverse Events 3 Years Number of Adverse Events in the study through 3 Years.
Trial Locations
- Locations (23)
Lankenau Institute for Medical Research
🇺🇸Bryn Mawr, Pennsylvania, United States
Premier Surgical Associates
🇺🇸Knoxville, Tennessee, United States
Black Hills Cardiovascular Research
🇺🇸Rapid City, South Dakota, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Bellin Memorial Hospital
🇺🇸Green Bay, Wisconsin, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Memorial Medical Center
🇺🇸Modesto, California, United States
Augusta Vascular Center
🇺🇸Augusta, Georgia, United States
DuPage Medical Group
🇺🇸Downers Grove, Illinois, United States
Rockford Cardiovascular Associates
🇺🇸Rockford, Illinois, United States
Cardiovascular Solutions, LLC
🇺🇸Shreveport, Louisiana, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Mercy Hospital/Metropolitan Cardiology Consultants
🇺🇸Coon Rapids, Minnesota, United States
Wake Heart Research
🇺🇸Raleigh, North Carolina, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
First Coast Cardiovascular Institute, P.A.
🇺🇸Jacksonville, Florida, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
St. Luke's Medical Center
🇺🇸Phoenix, Arizona, United States
Central Iowa Hospital Corporation
🇺🇸Des Moines, Iowa, United States
Sutter Memorial Hospital
🇺🇸Sacramento, California, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States