CompletedNot Applicable

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

United States1,843 participantsStarted 2014-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

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:
✕. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;

What they're measuring

The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)

Timeframe: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

Trial details

NCT IDNCT02060630

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

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