Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
NCT ID: NCT00504088
Last Updated: 2008-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
INTERVENTIONAL
2006-10-31
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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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Bypass
Silverhawk Plaque Excision
Eligibility Criteria
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Inclusion Criteria
* Willing and able, as evaluated by the PI, to provide Informed Consent
* Willing to undergo up to 5 years of clinical follow up visits as scheduled
* Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance
* Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot
* The patient must be \>18 years of age
* Target lesion(s) is located at or below the level of the superficial femoral artery
* Target lesion(s) is \>50% stenosed by quantitative vascular angiography
* Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy
Exclusion Criteria
* Patient has terminal or Stage 4 cancer
* Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure
* Previous stent in the target lesion
* Active infection at planned incision site
* The patient is a pregnant woman
* The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure
* Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification
18 Years
ALL
No
Sponsors
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FoxHollow Technologies
INDUSTRY
Principal Investigators
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James F. McKinsey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Los Angeles Cardiology/Good Samaritan
Los Angeles, California, United States
UC Davis Vascular Center
Sacramento, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
Stanford University Medical Center/Palo Alto VA
Stanford, California, United States
Heart & Vascular Clinic of Northern Colorado
Fort Collins, Colorado, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
University of Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St. Vincent
Indianapolis, Indiana, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Vascular Surgery Associates
Baton Rouge, Louisiana, United States
Beth Isreal (BIDMC)
Boston, Massachusetts, United States
St. Vincent Hospital
Worchester, Massachusetts, United States
William Beaumont/Southeast Surgical
Royal Oak, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
University of Mississippi
Jackson, Mississippi, United States
Alegent Health Research Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, United States
St. Vincent's Medical Center
New York, New York, United States
NY Weill Cornell Medical Center
New York, New York, United States
Columbia Presbyterian
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland VAMC
Cleveland, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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FHT-P-06-003
Identifier Type: -
Identifier Source: org_study_id