Study Results
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View full resultsBasic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2015-09-30
2021-07-31
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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Gore VIABAHN Endoprosthesis
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Gore VIABAHN Endoprosthesis
Interventions
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Gore VIABAHN Endoprosthesis
Eligibility Criteria
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Inclusion Criteria
* Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
* Patient demonstrates an Ankle Brachial Index (ABI) \<=0.9. If ABI \>0.9 or not measurable, patient is eligible for study if Toe Brachial Index is \<=0.5
* Patient has \>=50% in-stent restenosis and / or an occlusion in a previously implanted (\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
* Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
* Patient has a reference vessel diameter between 4.0 and 6.5mm
* Patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention
Exclusion Criteria
* Patient has a known intolerance to anticoagulation or antiplatelet therapy
* Patient has known coagulation disorder, including hypercoagulability.
* Patient has major distal amputation (above the transmetatarsal)
* Patient has any previous surgery in the target vessel
* Patient has had previous target vessel in-stent restenosis treated by relining with another stent
* Patient has untreated flow-limiting aortoiliac stenotic disease
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Soukas, MD
Role: PRINCIPAL_INVESTIGATOR
Miriam Hospital, Providence, RI
Locations
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Mount Sinai Medical Center
Miami, Florida, United States
Kaiser Foundation Hospital
Honolulu, Hawaii, United States
Rockford CardioVascular Associates
Rockford, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Covenant Medical Center, Inc.
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Midwest Aortic and Vascular Institute (MAVI)
North Kansas City, Missouri, United States
New York University Langone Medical Center
New York, New York, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
Sanford Health
Fargo, North Dakota, United States
Providence Heart Clinic
Portland, Oregon, United States
St. Vincent's Consultants in Cardiovascular Disease
Erie, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Greenville Hospital System
Greenville, South Carolina, United States
Texas Health Research - Presbyterian Heart and Vascular
Dallas, Texas, United States
Texas Health Research - Presbyterian Hospital of Plano
Plano, Texas, United States
Swedish Medical Center - Heart and Vascular Research
Seattle, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Klinikum Rosenheim
Rosenheim, , Germany
Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia
Reggio Emilia, , Italy
Skånes Universitetssjukhus
Malmo, , Sweden
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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ISR 14-04
Identifier Type: -
Identifier Source: org_study_id
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