Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2013-01-14
2019-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study cohort
All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.
EverFlex™ Self-Expanding Peripheral Stent System
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.
Interventions
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EverFlex™ Self-Expanding Peripheral Stent System
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.
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Medtronic Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Jon S Matsumura, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Krishna Rocha-Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Prairie Heart Institute
Locations
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St. Luke's Medical Center
Phoenix, Arizona, United States
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
Sparrow Hospital
Lansing, Michigan, United States
Mercy Hospital/Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Wake Heart Research
Raleigh, North Carolina, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Lankenau Institute for Medical Research
Bryn Mawr, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
Sanford Research
Sioux Falls, South Dakota, United States
Premier Surgical Associates
Knoxville, Tennessee, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-1001
Identifier Type: -
Identifier Source: org_study_id