Clinical trial NCT04191746: BEST vCLI Registry
Official title: BEST Critical Limb Ischemia (vCLI) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-12-10
Enrollment: 1009
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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
* 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

Primary outcomes:
measure: Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
timeFrame: 6 months
measure: Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants that died within 30 days of index procedure
timeFrame: 30 days
measure: Number of participants with amputation free survival as measured by patient report/verified by medical record review
timeFrame: 6 months
measure: Number of participants with amputation free survival as measured by patient report/verified by medical record review
timeFrame: 12 months
measure: Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
timeFrame: 6 months
measure: Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
timeFrame: 12 months
measure: Number of interventions per limb as measured by patient report/verified by medical record review
timeFrame: 6 months
measure: Number of interventions per limb as measured by patient report/verified by medical record review
timeFrame: 12 months
measure: Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
timeFrame: 6 months
measure: Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
timeFrame: 12 months
measure: Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
timeFrame: 6 months
measure: Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
timeFrame: 12 months
measure: Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
timeFrame: 6 months
measure: Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
timeFrame: 12 months
measure: 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
timeFrame: 6 months
measure: Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
timeFrame: Baseline
measure: Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
timeFrame: 6 month
measure: Quality of life as measure by the validated QOL tool (EuroQol) that will be administered throughout the study
timeFrame: 12 month
measure: Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
timeFrame: Baseline
measure: Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
timeFrame: 6 months
measure: Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Manesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Sreekanth Vemulapalli, MD
role: PRINCIPAL_INVESTIGATOR
References: