BEST vCLI Registry

Duke University

Status: Completed

Conditions: Critical Limb Ischemia

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04191746

1R01HL141213-01 (U.S. NIH Grant/Contract)

Pro00102178

Details and patient eligibility

About

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.

Full description

The study will be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.

Population: Patients over age 18 presenting with critical limb ischemia After initial enrollment at 40 study sites throughout the US. participants will complete follow-up 6 months and 12 months via call center telephone calls.

The study plan calls for enrollment of approximately 1,200 participants throughout the US that will then have 12 month followup that includes collection of medications, hospitalizations for collection of events.Additionally, the BEST-CLI trial will be gathering quality of life data and cost data using similar instruments, thus providing an opportunity for comparison between cost and quality of life analyses in a clinical trial versus in a real-world registry and collection of Quality of Life using validated instruments: EQ-5D, VASQOL, SF-12.and bill review to determine economic impact of disease.

Enrollment: 1,009 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,009 participants in 1 patient group

Participants with critical limb disease

Description:

This registry will collect data from participants with critical limb disease from Duke University and approximately 40 sites in North America.