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CompletedNCT02060630BEST-CLIUpdated Apr 11, 2023

Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

An interventional study of Open surgical revascularization and Endovascular revascularization in Critical Limb Ischemia, sponsored by Carelon Research. Completed at 161 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Carelon Research · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2022, 4 years 7 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
1,843
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Read the detailed description

Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.

02

Conditions studied

  • Critical Limb Ischemia

Keywords

  • Surgical revascularization
  • Endovascular revascularization
  • Amputation
  • Peripheral artery disease
  • Critical limb ischemia
  • claudication
  • leg pain
  • leg ulcer
  • gangrene
03

In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's enrollment of 1,843 is above the median of 45 across 233 interventional studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Carelon Research is the lead sponsor of 55 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, age 18 years or older.
  2. Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
  3. CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
  4. Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
  5. Adequate aortoiliac inflow.
  6. Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
  7. Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Presence of a popliteal aneurysm (>2 cm) in the index limb.
  2. Life expectancy of less than 2 years due to reasons other than PAOD.
  3. Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
  4. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
  5. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
  6. Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).

  7. Any of the following procedures performed on the index limb within 3 months prior to enrollment:

    1. Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
    2. Infrainguinal bypass with either venous or prosthetic conduit
  8. Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
  9. Current chemotherapy or radiation therapy.
  10. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures.
  11. Pregnancy or lactation.
  12. Administration of an investigational drug for PAD within 30 days of randomization.
  13. Participation in a clinical trial (except observational studies) within the previous 30 days.
  14. Prior enrollment or randomization into BEST-CLI.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,843 participants (actual)

Study arms

  • Other
    Available vein, open surg. revasc.

    Subjects with an available SSGSV cohort randomized to open surgical revascularization

    Procedure: Open surgical revascularization

  • Other
    Available vein, endovasc. revasc.

    Subjects with an available SSGSV cohort randomized to endovascular revascularization

    Device: Endovascular revascularization

  • Other
    Alternative conduit, open surg. revasc.

    Subjects with an alternative conduit cohort randomized to open surgical revascularization

    Procedure: Open surgical revascularization

  • Other
    Alternative conduit, endovasc. revasc.

    Subjects with an alternative conduit cohort randomized to endovascular revascularization

    Device: Endovascular revascularization

Interventions

  • ProcedureOpen surgical revascularization
  • DeviceEndovascular revascularization

    A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.

06

What researchers measure

Primary outcomes

  1. The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)

    * Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available * Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

Secondary outcomes

  1. Clinical: Re-intervention and amputation-free survival (cohort 1)

    Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  2. Clinical: Re-intervention and amputation-free survival (cohort 2)

    Time to re-intervention of the index leg, above ankle amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  3. Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)

    Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  4. Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)

    Time to re-intervention of the index leg, amputation of the index leg, or death within 30 days of index procedure, whichever occurs first in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  5. Clinical: Amputation-free survival (cohort 1)

    Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  6. Clinical: Amputation-free survival (cohort 2)

    Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  7. Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)

    Time to death within 30 days of index procedure in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  8. Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)

    Time to death within 30 days of index procedure in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  9. Clinical: Freedom from Myocardial Infarction (cohort 1)

    Time to myocardial infarction (MI) in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  10. Clinical: Freedom from Myocardial Infarction (cohort 2)

    Time to myocardial infarction (MI) in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  11. Clinical: Freedom from Stroke (cohort 1)

    Time to stroke in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  12. Clinical: Freedom from Stroke (cohort 2)

    Time to stroke in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  13. Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)

    Time to re-intervention (major and minor) in index leg in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  14. Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)

    Time to re-intervention (major and minor) in index leg in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  15. Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)

    Number of re-interventions (major and minor) in per limb salvaged in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  16. Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)

    Number of re-interventions (major and minor) in per limb salvaged in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  17. Clinical: Freedom from hemodynamic failure (cohort 1)

    Time to hemodynamic failure in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  18. Clinical: Freedom from hemodynamic failure (cohort 2)

    Time to hemodynamic failure in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  19. Clinical: Freedom from clinical failure (cohort 1)

    Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  20. Clinical: Freedom from clinical failure (cohort 2)

    Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  21. Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)

    Time to resolution of presenting CLI symptoms in the index limb in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  22. Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)

    Time to resolution of presenting CLI symptoms in the index limb in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  23. Clinical: Freedom from all-cause mortality (cohort 1)

    Time to all-cause mortality in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  24. Clinical: Freedom from all-cause mortality (cohort 2)

    Time to all-cause mortality in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  25. Functional: Quality of Life assessment using VasuQoL (cohort 1)

    VasuQOL measurements in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  26. Functional: Quality of Life assessment using VasuQoL (cohort 2)

    VasuQOL measurements in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  27. Functional: Quality of Life assessment using EuroQoL (cohort 1)

    EuroQOL measurements in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  28. Functional: Quality of Life assessment using EuroQoL (cohort 2)

    EuroQOL measurements in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  29. Functional: Function assessment using SF-12, PCS (cohort 1)

    Physical Component Summary (PCS) scores in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  30. Functional: Function assessment using SF-12, PCS (cohort 2)

    Physical Component Summary (PCS) scores in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  31. Functional: Function assessment using SF-12, MCS (cohort 1)

    Mental Component Summary (MCS) scores in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  32. Functional: Function assessment using SF-12, MCS (cohort 2)

    Mental Component Summary (MCS) scores in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  33. Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)

    Utility Index (SF-6D R2) scores in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  34. Functional: Function assessment using SF-12, SF-6D R2(cohort 2)

    Utility Index (SF-6D R2) scores in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  35. Functional: Numerical rating scale for Pain, Pain Now (cohort 1)

    Scores for Pain Now in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  36. Functional: Numerical rating scale for Pain, Pain Now (cohort 2)

    Scores for Pain Now in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  37. Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)

    Scores for Usual level of Pain during the last week in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  38. Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)

    Scores for Usual level of Pain during the last week in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  39. Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)

    Scores for Best level of Pain during the last week in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  40. Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)

    Scores for Best level of Pain during the last week in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  41. Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)

    Scores for Worst level of Pain during the last week in subjects with SSGSV available

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  42. Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)

    Scores for Worst level of Pain during the last week in subjects without available SSGSV

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  43. Function: Six-minute walk test (cohort 1)

    Six-minute walk test measurements in subjects with SSGSV available. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

  44. Function: Six-minute walk test (cohort 2)

    Six-minute walk test measurements in subjects without available SSGSV. The six-minute walk test was performed at a subset of clinical sites (for whom this test was standard of care) and was limited to patients for whom rest pain, wounds, or foot surgery (recent or anticipated) did not preclude weight bearing

    Time frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

07

Study locations

161 sites
  • The University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Arizona Heart Hospital
    Phoenix, Arizona 85016, United States
  • University of Arizona - Banner University Medical Center
    Tucson, Arizona 85719, United States
  • Carondelet Heart & Vascular Institute
    Tucson, Arizona 85745, United States
  • University of Arkansas for Medical Services
    Little Rock, Arkansas 72205, United States
  • University of California - Irvine
    Irvine, California 92697, United States
  • San Diego VAMC
    La Jolla, California 92037, United States
  • UC San Diego Sulpizio Cardiovascular Center
    La Jolla, California 92037, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Loma Linda VA Medical Center
    Loma Linda, California 92357, United States
  • VA Long Beach Healthcare System
    Long Beach, California 90822, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • VA Greater Los Angeles
    Los Angeles, California 90073, United States
  • Keck Medical Center of USC
    Los Angeles, California 90089, United States
  • UCLA-Gonda Vascular Surgery
    Los Angeles, California 90095, United States
  • VA Palo Alto Health Care
    Palo Alto, California 94304, United States
  • Sacramento VA Medical Center
    Sacramento, California 95655, United States
  • University of California Davis Medical Center
    Sacramento, California 95817, United States
  • Kaiser Permanente (San Diego)
    San Diego, California 92123, United States
  • Kaiser Permanente Northern California
    San Francisco, California 94118, United States
  • San Francisco Veterans Affairs Medical Center
    San Francisco, California 94121, United States
  • University of California-San Francisco Medical Center
    San Francisco, California 94143, United States
  • Stanford Hospital
    Stanford, California 94305, United States
  • Harbor - UCLA Medical Center
    Torrance, California 90509, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Denver Health
    Denver, Colorado 80024, United States
  • Vascular Institute of the Rockies
    Denver, Colorado 80218, United States
  • Rocky Mountain Regional VA
    Denver, Colorado 80220, United States
  • St. Francis Hospital and Medical Center
    Hartford, Connecticut 06105, United States
  • Yale-New Haven Hospital
    New Haven, Connecticut 06510, United States
  • West Haven VAMC
    West Haven, Connecticut 06516, United States
  • Medstar Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • GW Medical Faculty Associates, Inc.
    Washington, District of Columbia 20037, United States
  • University of Florida (Gainesville)
    Gainesville, Florida 32610, United States
  • Mount Sinai Miami
    Miami Springs, Florida 33140, United States
  • Baptist Hospital of Miami
    Miami, Florida 33176, United States
  • Florida Hospital Ocala
    Ocala, Florida 34471, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Tampa VAMC
    Tampa, Florida 33612, United States
  • Emory University
    Atlanta, Georgia 30303, United States
  • Atlanta VA Medical Center
    Decatur, Georgia 30033, United States
  • Kaiser Foundation Hospital
    Honolulu, Hawaii 96819, United States
  • Central DuPage Hospital (Cadence)
    Chicago, Illinois 60190, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Chicago Medicine
    Chicago, Illinois 60637, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
  • Northwestern Memorial Hospital
    Winfield, Illinois 601611, United States
  • Indiana University Medical School
    Indianapolis, Indiana 46202, United States
  • Mercy Hospital Medical Center
    West Des Moines, Iowa 50266, United States
  • Ochsner Medical Center
    New Orleans, Louisiana 70121, United States
  • University Health System: LSU Health Sciences
    Shreveport, Louisiana 71130, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • University of Maryland Medical System
    Baltimore, Maryland 21201, United States
  • Johns Hopkins Hospital
    Baltimore, Maryland 21210, United States
  • Loyola University Medical Center
    Baltimore, Maryland 21210, United States
  • MedStar Union Memorial Hospital
    Baltimore, Maryland 21218, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • VA Boston Healthcare System
    Boston, Massachusetts 02132, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Steward St. Elizabeth's Medical Center
    Brighton, Massachusetts 02135, United States
  • South Shore Hospital
    Weymouth, Massachusetts 02189, United States
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
  • VA Ann Arbor Healthcare System
    Ann Arbor, Michigan 48105, United States
  • Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Health System
    Ann Arbor, Michigan 48109, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Michigan Vascular Center
    Flint, Michigan 48507, United States
  • Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
  • Minneapolis Heart Hospital/Abbott Northwestern Hosp.
    Minneapolis, Minnesota 55407, United States
  • Minneapolis VAMC
    Minneapolis, Minnesota 55417, United States
  • Mayo Clinic
    Rochester, Minnesota 55901, United States
  • University of Missouri
    Columbia, Missouri 65212, United States
  • Midwest Aortic Vascular Institute
    Kansas City, Missouri 64116, United States
  • St. Louis VA Medical Center
    Saint Louis, Missouri 63106, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Dartmouth Hitchcock Medical Center
    Hanover, New Hampshire 03756, United States
  • Deborah Heart and Lung Center
    Browns Mills, New Jersey 08015, United States
  • Englewood Hospital and Medical Center
    Englewood, New Jersey 07631, United States
  • Rutgers New Jersey Medical School
    Newark, New Jersey 07103, United States
  • Holy Name Medical Center
    Teaneck, New Jersey 07666, United States
  • New Mexico Heart Institute
    Albuquerque, New Mexico 87102, United States
  • New Mexico VA Medical Center
    Albuquerque, New Mexico 87108, United States
  • Albany Medical Center
    Albany, New York 12208, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • VA Western NY Healthcare System
    Buffalo, New York 14215, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Vascular Health Partners
    Queensbury, New York 12804, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Staten Island University Hospital
    Staten Island, New York 10305, United States
  • Stony Brook Medicine
    Stony Brook, New York 11794-8191, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13215, United States
  • Westchester Medical Center
    Valhalla, New York 10595, United States
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
  • Duke University
    Durham, North Carolina 27705, United States

Showing the first 100 of 161 sites across 5 countries.

08

References and documents

Publications

  • Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK, Hamza TH, Assmann SF, Creager MA, Cziraky MJ, Dake MD, Jaff MR, Reid D, Siami FS, Sopko G, White CJ, van Over M, Strong MB, Villarreal MF, McKean M, Azene E, Azarbal A, Barleben A, Chew DK, Clavijo LC, Douville Y, Findeiss L, Garg N, Gasper W, Giles KA, Goodney PP, Hawkins BM, Herman CR, Kalish JA, Koopmann MC, Laskowski IA, Mena-Hurtado C, Motaganahalli R, Rowe VL, Schanzer A, Schneider PA, Siracuse JJ, Venermo M, Rosenfield K; BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Dec 22;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7. PubMed 36342173 ↗
  • Albaghdadi MS, Young MN, Chowdhury MM, Assmann S, Hamza T, Siami S, Villarreal M, Strong M, Menard M, Farber A, Rosenfield K. Clinical practice patterns and ascertainment bias for cardiovascular events in a randomized trial: A survey of investigators in the BEST-CLI trial. Vasc Med. 2021 Apr;26(2):180-186. doi: 10.1177/1358863X21995897. PubMed 33825577 ↗
  • Rathakrishnan B, Secemsky EA. Turning the tide: Evolution of below-the-knee endovascular intervention. Vasc Med. 2021 Feb;26(1):26-27. doi: 10.1177/1358863X20978281. Epub 2020 Dec 14. No abstract available. PubMed 33314979 ↗
  • Powell R, Menard M, Farber A, Rosenfield K, Goodney P, Gray B, Lookstein R, Pena C, Schermerhorn M. Comparison of specialties participating in the BEST-CLI trial to specialists treating peripheral arterial disease nationally. J Vasc Surg. 2019 May;69(5):1505-1509. doi: 10.1016/j.jvs.2018.08.188. PubMed 31010516 ↗
  • Farber A, Rosenfield K, Siami FS, Strong M, Menard M. The BEST-CLI trial is nearing the finish line and promises to be worth the wait. J Vasc Surg. 2019 Feb;69(2):470-481.e2. doi: 10.1016/j.jvs.2018.05.255. PubMed 30683195 ↗
  • Menard MT, Farber A, Assmann SF, Choudhry NK, Conte MS, Creager MA, Dake MD, Jaff MR, Kaufman JA, Powell RJ, Reid DM, Siami FS, Sopko G, White CJ, Rosenfield K. Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003219. doi: 10.1161/JAHA.116.003219. PubMed 27402237 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02060630
Lead sponsor
Carelon Research
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Boston Medical Center, National Heart, Lung, and Blood Institute (NHLBI), Abbott, Bard Ltd, Boston Scientific Corporation, Cordis Corporation, Abbott Medical Devices, Canadian Society for Vascular Surgery, Eastern Vascular Society, W.L.Gore & Associates, Midwest Vascular Society, New England Society for Vascular Surgery, Society for Clinical Vascular Surgery, Society for Interventional Radiology, Southern Vascular Society, Society for Vascular Medicine, Society for Vascular Surgery, Vascular and Endovascular Surgery Society, Vascular Interventional Advances, Western Vascular Society
Responsible party
Sponsor
First posted
Feb 12, 2014
Start date
Aug 2014
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Last update
Apr 11, 2023

Study contacts

Matthew Menard, MD
principal investigator · Brigham and Women's Hospital
Alik Farber, MD
principal investigator · Boston University
Kenneth Rosenfield, MD
principal investigator · Massachusetts General Hospital
Mark Cziraky, PharmD, CLS
principal investigator · Carelon Research
Taye Hamza, PhD
principal investigator · Carelon Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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