Study Stopped
Company decision to halt study
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
PROOF
1 other identifier
interventional
N/A
1 country
31
Brief Summary
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedAugust 20, 2008
August 1, 2007
July 17, 2007
August 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major amputation-free survival
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
Los Angeles Cardiology/Good Samaritan
Los Angeles, California, 90017, United States
UC Davis Vascular Center
Sacramento, California, 95817, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Stanford University Medical Center/Palo Alto VA
Stanford, California, 94306, United States
Heart & Vascular Clinic of Northern Colorado
Fort Collins, Colorado, 80523, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
St. Vincent
Indianapolis, Indiana, 46260, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Vascular Surgery Associates
Baton Rouge, Louisiana, 70809, United States
Beth Isreal (BIDMC)
Boston, Massachusetts, 02215, United States
St. Vincent Hospital
Worchester, Massachusetts, 01608, United States
William Beaumont/Southeast Surgical
Royal Oak, Michigan, 48073, United States
Providence Hospital
Southfield, Michigan, 48075, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Alegent Health Research Center
Omaha, Nebraska, 68152, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 87102, United States
St. Vincent's Medical Center
New York, New York, 10011, United States
NY Weill Cornell Medical Center
New York, New York, 10021, United States
Columbia Presbyterian
New York, New York, 10604, United States
Duke University Medical Center
Durham, North Carolina, 27712, United States
Cleveland VAMC
Cleveland, Ohio, 44106, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Sentara Heart Hospital
Norfolk, Virginia, 23507, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James F. McKinsey, M.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 19, 2007
Study Start
October 1, 2006
Last Updated
August 20, 2008
Record last verified: 2007-08