Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia (PROOF)

FoxHollow Technologies

Status and phase

Terminated

Phase 4

Conditions

Peripheral Vascular Diseases

Treatments

Procedure: Bypass

Procedure: Silverhawk Plaque Excision

Study type

Interventional

Funder types

Industry

Identifiers

FHT-P-06-003

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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