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Not Recruiting
Trial ID: NCT00504088
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Professor of Surgery (Vascular), Emeritus
Dr. Walter C. Chidester Professor
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
procedure: Bypass
procedure: SilverHawk Plaque Excision
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jason Lee
6507255227