Peripheral Vascular Diseases
Conditions
Keywords
CLI, Critical Limb Ischemia, PAD, Peripheral Arterial Disease, Artherosclerosis, Leg Pain, Cardiovascular, Artherectomy, Bypass, Peripheral Bypass, PROOF
Brief summary
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Interventions
PROCEDUREBypass
PROCEDURESilverhawk Plaque Excision
Sponsors
FoxHollow Technologies
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major amputation-free survival | — |
Countries
United States
Outcome results
None listed