GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
NCT ID: NCT00541307
Last Updated: 2012-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2007-10-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GORE VIABHAN Endoprothesis
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Interventions
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Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Eligibility Criteria
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Inclusion Criteria
* ABI (ankle-brachial index) \< 0.9 or TBI (toe-brachial index) \< 0.5 if ABI is \>0.9
* Stenosis (\>50%) or occlusion of native SFA (superficial femoral artery) \>5cm
* Orifice and 1 cm of SFA are patent
* Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
* At least 1 patent run off vessel
* Guidewire and deliver system successfully traversed the lesion
Exclusion Criteria
* Any previous stenting or surgery in the target vessel
* Femoral or popliteal aneurysm of target vessel
* No patent tibial arteries
* Prior ipsilateral femoral artery bypass
* Major distal amputation (above the transmetatarsal) in either limb
* Patients with known sensitivity to Heparin
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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Richard Saxon, MD
Role: PRINCIPAL_INVESTIGATOR
North County Radiology Medial Group Inc.
Locations
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Tri-City Medical Center
Oceanside, California, United States
Mercy Hospital and Medical Center
Chicago, Illinois, United States
Columbia Surgical Associates
Columbia, Missouri, United States
Baylor University Medical Center
Dallas, Texas, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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VPR 07-03
Identifier Type: -
Identifier Source: org_study_id