Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.
Inclusion Criteria:
Exclusion Criteria:
Presence of a popliteal aneurysm (>2 cm) in the index limb.
Life expectancy of less than 2 years due to reasons other than PAOD.
Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).
Any of the following procedures performed on the index limb within 3 months prior to enrollment:
Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
Current chemotherapy or radiation therapy.
Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures.
Pregnancy or lactation.
Administration of an investigational drug for PAD within 30 days of randomization.
Participation in a clinical trial (except observational studies) within the previous 30 days.
Prior enrollment or randomization into BEST-CLI.
Cleveland, Ohio 44106, United States
Greenville, South Carolina 29605, United States