Trial Purpose and Description
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.
Ages: 18 years and older
- Male or female, age 18 years or older.
- Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
- CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
- Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
- Adequate aortoiliac inflow.
- Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
- Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
- 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:
- Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
- Infrainguinal bypass with either venous or prosthetic conduit
- 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.
New England Research Institute
Dates: 06/08/2015 - 12/31/2018
Last Updated: 01/08/2016
Study HIC#: 1501015265