BEST vCLI Registry

NCT04191746 | Completed

• 2 other identifiers: Pro001021781R01HL141213-01
• Study Type: observational
• Target: 1,009
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)

  Number of participants in the registry with major limb events as reported by participants and confirmed by medical records

  6 months

• Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)

  Number of participants in the registry with major limb events as reported by participants and confirmed by medical records

  12 months

Secondary Outcomes (20)

• Number of participants that died within 30 days of index procedure

  30 days

• Number of participants with amputation free survival as measured by patient report/verified by medical record review

  6 months

• Number of participants with amputation free survival as measured by patient report/verified by medical record review

  12 months

• Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review

  6 months

• Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with critical limb ischemia Phase I: While the BEST-CLI Trial is actively enrolling, the BEST-Registry will only enroll patients who first screen fail from BEST-CLI. Phase II: After BEST-CLI officially finishes enrollment, screen failure for BEST-CLI will no longer be required for enrollment into the BEST-Registry 1200 patients, across approximately 40 sites participating in BEST-CLI clinical trial.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Manesh Patel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Sreekanth Vemulapalli, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: December 10, 2019
• Study Start: December 9, 2019
• Primary Completion: June 30, 2023
• Study Completion: September 25, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)