Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Stopped early · Phase 4

Conditions studied: Peripheral Vascular Diseases

In brief

To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs

Key facts

Study ID

NCT00504088

Run by

FoxHollow Technologies

Starts

2006-10-01

Last updated by the study team

2008-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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