Clinical trial NCT01680835: EverFlex Post Approval Study
Official title: The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lower Extremity Arterial Disease
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: General Inclusion Criteria

1. Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts), or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries suitable for primary stenting.
2. Has a Rutherford Clinical Category Score of 2, 3 or 4.
3. Is willing to comply with all follow-up evaluations at the specified times.
4. Is ≥ to18 years old.
5. Provides written informed consent prior to enrollment in the study.

Angiographic Inclusion Criteria Subjects must meet all of the following angiographic inclusion criteria. The implanting physician bases all angiographic inclusion criteria on visual determination at the time of the procedure.

1. Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 3 cm above the cortical margin of the femur and proximal point at least 1 cm below the origin of the profunda femoralis measured by straight posteroanterior (PA) view for distal lesions, ipsilateral oblique view for proximal lesions.
2. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s).
3. Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.
4. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.
5. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not also require treatment for significant (\> 50% stenosis or occlusion) stenosis during the index procedure.

General Exclusion Criteria

1. Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol.
3. Has known hypersensitivity to nickel-titanium.
4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
5. Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
6. Has life expectancy of less than 1 year.
7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
8. Has previously been enrolled in the DURABILITY PAS study.
9. Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure.
10. Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
11. Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
12. Has any co-morbid condition that precludes endovascular treatment.

Angiographic Exclusion Criteria The subject must not meet any of the following angiographic exclusion criteria. The implanting physician bases all angiographic exclusion criteria on visual determination at the time of the procedure.

1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
2. Presence of significant (\> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
3. Aneurysmal target vessel.
4. Presence of an acute intraluminal thrombus at the proposed lesion site.
5. Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure.
6. Focal popliteal disease in the absence of femoral disease.

Primary outcomes:
measure: Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
timeFrame: 3 Years
Secondary outcomes:
measure: Secondary Outcome - Freedom From Stent Fracture
timeFrame: 1, 2 and 3 years
measure: Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years
timeFrame: 1 and 2 years
measure: Secondary Outcome - Freedom From 36-month Amputation
timeFrame: 3 Years
measure: Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
timeFrame: 3 Years
measure: Secondary Outcome - Number of Participants Free From Acute Death
timeFrame: 30 days
measure: Secondary Outcome - Number of Successfully Implanted Stents
timeFrame: At procedure
measure: Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year
timeFrame: 1 Year
measure: Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year
timeFrame: 1 Year
measure: Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
timeFrame: 1 Year
measure: Secondary Outcome - Number of Adverse Events
timeFrame: 3 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute, P.A.
state: Florida
city: Augusta
country: United States
facility: Augusta Vascular Center
state: Georgia
city: Downers Grove
country: United States
facility: DuPage Medical Group
state: Illinois
city: Rockford
country: United States
facility: Rockford Cardiovascular Associates
state: Illinois
city: Des Moines
country: United States
facility: Central Iowa Hospital Corporation
state: Iowa
city: Shreveport
country: United States
facility: Cardiovascular Solutions, LLC
state: Louisiana
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital/Metropolitan Cardiology Consultants
state: Minnesota
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Knoxville
country: United States
facility: Premier Surgical Associates
state: Tennessee
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jon S Matsumura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prairie Heart Institute
name: Krishna Rocha-Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: