BEST vCLI Registry

NCT ID: NCT04191746

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1009 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2023-09-25

Brief Summary

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.

Detailed 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.

Conditions

Critical Limb Ischemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with critical limb disease

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

No interventions assigned to this group

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Sreekanth Vemulapalli, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1R01HL141213-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00102178

Identifier Type: -

Identifier Source: org_study_id