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BEST vCLI Registry (BEST)

  • Study HIC#:2000026922REG
  • Last Updated:07/15/2021

For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.

  • Age18 years and older
  • GenderBoth
  • Start Date08/06/2020
  • End Date10/30/2021

Trial Purpose and Description

Multi-center Registry evaluating the real-world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.

Eligibility Criteria

Inclusion Criteria:

  • Male or female
  • age 18 years or older
  • Infrainguinal peripheral artery disease (occlusive disease of the arteries below the inguinal ligament)
  • Critical limb ischemia, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6
  • Documented consideration for enrollment in the BEST-CLI Trial with documented failure to meet inclusion / exclusion criteria. Phase ll After BEST CLI official enrollment ends, this inclusion criteria will be removed.
  • Willingness to comply with vCLI 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 peripheral artery disease
  • Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
  • Current chemotherapy or radiation therapy
  • Pregnancy or lactation
  • Administration of an investigational drug for peripheral artery disease within 30 days of randomization
  • Participation in a clinical trial (except observational studies) within the previous 30 days
  • Prior enrollment or randomization into the BEST-CLI trial

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