Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

Completed · Not applicable

Conditions studied: Critical Limb Ischemia

In brief

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.

Key facts

Study ID

NCT02060630

Run by

Carelon Research

People needed

1843

Starts

2014-08-01

Expected to finish

2022-03-01

Last updated by the study team

2023-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Heart Hospital — Phoenix, Arizona, United States
• University of Arizona - Banner University Medical Center — Tucson, Arizona, United States
• Carondelet Heart & Vascular Institute — Tucson, Arizona, United States
• University of Arkansas for Medical Services — Little Rock, Arkansas, United States
• University of California - Irvine — Irvine, California, United States
• San Diego VAMC — La Jolla, California, United States
• UC San Diego Sulpizio Cardiovascular Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Loma Linda VA Medical Center — Loma Linda, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• VA Greater Los Angeles — Los Angeles, California, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• UCLA-Gonda Vascular Surgery — Los Angeles, California, United States
• VA Palo Alto Health Care — Palo Alto, California, United States
• Sacramento VA Medical Center — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Kaiser Permanente (San Diego) — San Diego, California, United States
• Kaiser Permanente Northern California — San Francisco, California, United States
• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
• University of California-San Francisco Medical Center — San Francisco, California, United States
• Stanford Hospital — Stanford, California, United States
• Harbor - UCLA Medical Center — Torrance, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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