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
- 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.
- 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.
- 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