Peripheral Vascular Diseases Clinical Trial
— PROOFOfficial title:
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
NCT number | NCT00504088 |
Other study ID # | FHT-P-06-003 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | July 17, 2007 |
Last updated | August 19, 2008 |
Start date | October 2006 |
Verified date | August 2007 |
Source | FoxHollow Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Status | Terminated |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6) - 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 cardiac or cardiovascular comorbidities that would make surgery inappropriate - 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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New Mexico Heart Institute, PA | Albuquerque | New Mexico |
United States | Vascular Surgery Associates | Baton Rouge | Louisiana |
United States | University of Alabama, Birmingham | Birmingham | Alabama |
United States | Beth Isreal (BIDMC) | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland VAMC | Cleveland | Ohio |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Heart & Vascular Clinic of Northern Colorado | Fort Collins | Colorado |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | St. Vincent | Indianapolis | Indiana |
United States | University of Mississippi | Jackson | Mississippi |
United States | Los Angeles Cardiology/Good Samaritan | Los Angeles | California |
United States | Holmes Regional Medical Center | Melbourne | Florida |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Columbia Presbyterian | New York | New York |
United States | NY Weill Cornell Medical Center | New York | New York |
United States | St. Vincent's Medical Center | New York | New York |
United States | Sentara Heart Hospital | Norfolk | Virginia |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | Alegent Health Research Center | Omaha | Nebraska |
United States | Sacred Heart Hospital | Pensacola | Florida |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | William Beaumont/Southeast Surgical | Royal Oak | Michigan |
United States | UC Davis Vascular Center | Sacramento | California |
United States | San Francisco VA Medical Center | San Francisco | California |
United States | Providence Hospital | Southfield | Michigan |
United States | Stanford University Medical Center/Palo Alto VA | Stanford | California |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | St. Vincent Hospital | Worchester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
FoxHollow Technologies |
United States,
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---|---|---|---|---|
Primary | Major amputation-free survival |
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