BEST-CLI: Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST)

Project: Research project

Project Details

Description

The BEST-CLI Trial is a multicenter randomized trial of best endovascular (EVT) or best open surgical (OPEN) revascularization in patients with CLI and infrainguinal arterial occlusive disease who are candidates for both open and endovascular treatment. The trial has a superiority design and has the following specific aims:

Primary Aim: To compare the primary endpoint event rate of Major Adverse Limb Event (MALE)-free survival in subjects with CLI randomized to best endovascular (EVT) revascularization to the rate in those randomized to best open surgery (OPEN). Best revascularization, whether EVT or OPEN, is defined as the technique deemed most appropriate for the subject by the operator(s), with respect to the index limb.

Treatment comparisons (EVT vs. OPEN) will be made in two cohorts (See Section 3.1): 1) patients with an available SSGSV (total N=1620); and 2) patients without a SSGSV (in whom an alternative conduit is to be used if randomized to OPEN) (total N=480).

Secondary Aims:
1) To compare other clinical event rates (see secondary endpoints in Section 3.2) of subjects with CLI randomized to best EVT or best OPEN revascularization
2) To compare functional status and quality of life after 2 years of follow-up in subjects with CLI randomized to best EVT or best OPEN revascularization
3) To compare costs of 2 years of follow-up associated with treatment of subjects with CLI randomized to best EVT or best OPEN revascularization. Cost-effectiveness (C-E) will be compared between the 2 treatment groups.
StatusActive
Effective start/end date8/7/145/31/21

Funding

  • New England Research Institutes, Inc. (Agr. 8/7/14 // U01HL107407)
  • National Heart, Lung, and Blood Institute (Agr. 8/7/14 // U01HL107407)

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