BEST vCLI Registry (BEST)

BEST Critical Limb Ischemia (vCLI) Registry

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.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia

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.

• Study Type: Observational
• Enrollment (Actual): 1009

Contacts and Locations

• Study Contact: Name: Tina Harding, BSN; Phone Number: 919-668-8430; Email: tina.harding@duke.edu
• Study Contact Backup: Name: Abigail Patterson, BA; Phone Number: 919-668-5977; Email: abigail.patterson@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that died within 30 days of index procedure	Collect composite of MALE or perioperative death within 30 days of index procedure using patient/proxy information qualified by medical records.	30 days
Number of participants with amputation free survival as measured by patient report/verified by medical record review	Interviews completed at 6 months with participants that note no hospitalization for amputation and verified by medical records	6 months
Number of participants with amputation free survival as measured by patient report/verified by medical record review	Interviews completed at 12 months with participants that note no hospitalization for amputation and verified by medical records	12 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review	At 6 month visit, the number of participants that did not report additional procedures such as surgery or angiography.in the affected leg	6 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review	At 12 month visit, the number of participants that did not report additional procedures such as surgery or angiography.in the affected leg	12 months
Number of interventions per limb as measured by patient report/verified by medical record review	Interventions consist of need to be hospitalized for a form of revascularization	6 months
Number of interventions per limb as measured by patient report/verified by medical record review	Interventions consist of need to be hospitalized for a form of revascularization	12 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review	Limb revascularization failure is loss of circulation to the limb that has procedural revascularization previously performed that is non functioning	6 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review	Limb revascularization failure is loss of circulation to the limb that has procedural revascularization previously performed that is non functioning	12 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review	Number of participants that answered no to the question "Was your hospitalization for a Heart Attack(MI) at 6 months verified by medical record.	6 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review	Number of participants that answered no to the question "Was your hospitalization for a Heart Attack(MI) at 12 months verified by medical record.	12 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review	Stroke is inclusive of a cerebral vascular including a ischemic, hemorrhagic or a TIA event.	6 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review	Stroke is inclusive of a cerebral vascular including a ischemic, hemorhagic or a TIA event.	12 months
Number of participants that did not have a periprocedural (30 day) major adverse cardiac events as measured by patient report/verified by medical record review	Events that occur during a revascularization procedure including cardiovascular events such as Myocardial Infarction and stoke.	6 months
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study	The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression. I also includes a 0-100 scale regarding participants assessment of health.	Baseline
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study	The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression. I also includes a 0-100 scale regarding participants assessment of health.	6 month
Quality of life as measure by the validated QOL tool (EuroQol) that will be administered throughout the study	The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression with a range of 5 answers. I also includes a 0-100 scale regarding participants assessment of health.	12 month
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study	The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view	Baseline
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study	The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view	6 months
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study	The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Manesh Patel, MD, Duke University; Principal Investigator: Sreekanth Vemulapalli, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: Pro00102178; 1R01HL141213-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No