Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- procedure : SilverHawk Plaque Excision
- procedure : Bypass
Phase: Phase 4
Ages Eligible For Study:
- 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