Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Not Recruiting

Trial ID: NCT00504088


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

Official Title

Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Stanford Investigator(s)

E. John Harris Jr.
E. John Harris Jr.

Professor of Surgery (Vascular), Emeritus

Ronald L. Dalman MD
Ronald L. Dalman MD

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

   - 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

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee