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AzTrials

Critical Limb IschemiaBEST-CLINCT02060630

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

A study testing Open surgical revascularization and Endovascular revascularization in people with Critical Limb Ischemia, run by Carelon Research at 161 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Limb Ischemia
What is being tested?
Open surgical revascularization and Endovascular revascularization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,843 participants
Where
161 sitesin 5 countries
Study dates
Aug 2014to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 18 years or older.
  • Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
  • CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
  • Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
  • Adequate aortoiliac inflow.
  • 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.
  • Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Who cannot join

  • Presence of a popliteal aneurysm (>2 cm) in the index limb.
  • Life expectancy of less than 2 years due to reasons other than PAOD.
  • Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
  • Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
  • Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
  • 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).
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  • Any of the following procedures performed on the index limb within 3 months prior to enrollment:
  • Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
  • Infrainguinal bypass with either venous or prosthetic conduit
  • Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
  • Current chemotherapy or radiation therapy.
  • 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.
  • Pregnancy or lactation.
  • Administration of an investigational drug for PAD within 30 days of randomization.
  • Participation in a clinical trial (except observational studies) within the previous 30 days.
  • Prior enrollment or randomization into BEST-CLI.

Trial locations and contacts

161 sites in 5 countries.

161 sites in 5 countries

United States144 sites

  • Albany Medical Center

    Albany, New York, 12208

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • New Mexico VA Medical Center

    Albuquerque, New Mexico, 87108

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

  • Michigan Heart/St. Joseph Mercy Ann Arbor Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30303

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Maryland Medical System

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21210

  • Loyola University Medical Center

    Baltimore, Maryland, 21210

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • VA Boston Healthcare System

    Boston, Massachusetts, 02132

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Steward St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • VA Western NY Healthcare System

    Buffalo, New York, 14215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • CAMC Clinical Trials Center

    Charleston, West Virginia, 25304

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Central DuPage Hospital (Cadence)

    Chicago, Illinois, 60190

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medicine

    Chicago, Illinois, 60637

  • University Hospitals of Cleveland/Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44109

  • University of Missouri

    Columbia, Missouri, 65212

  • The Ohio State University

    Columbus, Ohio, 43210

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Dallas VA Medical Center

    Dallas, Texas, 75390

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Denver Health

    Denver, Colorado, 80024

  • Vascular Institute of the Rockies

    Denver, Colorado, 80218

  • Rocky Mountain Regional VA

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27705

  • Durham VAMC

    Durham, North Carolina, 27705

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Michigan Vascular Center

    Flint, Michigan, 48507

  • University of Florida (Gainesville)

    Gainesville, Florida, 32610

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Prisma Health-Upstate (Formerly Greenville Memorial Hospital)

    Greenville, South Carolina, 29605

  • Dartmouth Hitchcock Medical Center

    Hanover, New Hampshire, 03756

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Kaiser Foundation Hospital

    Honolulu, Hawaii, 96819

  • Memorial Hermann Hospital TMC

    Houston, Texas, 77030

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

  • Indiana University Medical School

    Indianapolis, Indiana, 46202

  • University of California - Irvine

    Irvine, California, 92697

  • Midwest Aortic Vascular Institute

    Kansas City, Missouri, 64116

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

  • San Diego VAMC

    La Jolla, California, 92037

  • UC San Diego Sulpizio Cardiovascular Center

    La Jolla, California, 92037

  • University of Arkansas for Medical Services

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Loma Linda VA Medical Center

    Loma Linda, California, 92357

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • VA Greater Los Angeles

    Los Angeles, California, 90073

  • Keck Medical Center of USC

    Los Angeles, California, 90089

  • UCLA-Gonda Vascular Surgery

    Los Angeles, California, 90095

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706

  • Meriter Wisconsin Heart

    Madison, Wisconsin, 53713

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Mount Sinai Miami

    Miami Springs, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Milwaukee VAMC

    Milwaukee, Wisconsin, 53295

  • Minneapolis Heart Hospital/Abbott Northwestern Hosp.

    Minneapolis, Minnesota, 55407

  • Minneapolis VAMC

    Minneapolis, Minnesota, 55417

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Sentara Vascular Specialists

    Norfolk, Virginia, 23507

  • Florida Hospital Ocala

    Ocala, Florida, 34471

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • VA Palo Alto Health Care

    Palo Alto, California, 94304

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Arizona Heart Hospital

    Phoenix, Arizona, 85016

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

  • The Miriam Hospital/Brown Medical School

    Providence, Rhode Island, 02906

  • Vascular Health Partners

    Queensbury, New York, 12804

  • North Carolina Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55901

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sacramento VA Medical Center

    Sacramento, California, 95655

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • The University of Utah

    Salt Lake City, Utah, 84132

  • Kaiser Permanente (San Diego)

    San Diego, California, 92123

  • Kaiser Permanente Northern California

    San Francisco, California, 94118

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121

  • University of California-San Francisco Medical Center

    San Francisco, California, 94143

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University Health System: LSU Health Sciences

    Shreveport, Louisiana, 71130

  • North Central Heart Institute

    Sioux Falls, South Dakota, 57108

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • St. Louis VA Medical Center

    St Louis, Missouri, 63106

  • Stanford Hospital

    Stanford, California, 94305

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Stony Brook Medicine

    Stony Brook, New York, 11794-8191

  • SUNY Upstate Medical University

    Syracuse, New York, 13215

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Tampa VAMC

    Tampa, Florida, 33612

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Scott and White - Temple

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Toledo Medical Center

    Toledo, Ohio, 43615

  • Harbor - UCLA Medical Center

    Torrance, California, 90509

  • University of Arizona - Banner University Medical Center

    Tucson, Arizona, 85719

  • Carondelet Heart & Vascular Institute

    Tucson, Arizona, 85745

  • University of Oklahoma College of Medicine at Tulsa

    Tulsa, Oklahoma, 74135

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • GW Medical Faculty Associates, Inc.

    Washington D.C., District of Columbia, 20037

  • Mercy Hospital Medical Center

    West Des Moines, Iowa, 50266

  • West Haven VAMC

    West Haven, Connecticut, 06516

  • South Shore Hospital

    Weymouth, Massachusetts, 02189

  • Northwestern Memorial Hospital

    Winfield, Illinois, 601611

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Pinnacle Health System

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Canada12 sites

  • Queen Elizabeth II Health Science Center

    Halifax, Nova Scotia, B3H3A7

  • University of Western Ontario

    London, Ontario, N6A5W9

  • McGill

    Montreal, Quebec, H3A1A1

  • Jewish General Hostpital

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y4E9

  • Chu de Quebec

    Québec, Quebec, G1L 3L5

  • Regina Qu'Appelle

    Regina, Saskatchewan, S4P 0W5

  • St. Paul's Hospital

    Saskatoon, Saskatchewan, S7M0Z9

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z1M9

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

New Zealand3 sites

  • Auckland City Hospital

    Grafton, Auckland, 1023

  • Waikato Hospital

    Hamilton, Waikato Region, 3240

  • Wellington Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Finland1 site

  • Helsinki University Hospital

    Helsinki, F100029

Other trials in Finland

Italy1 site

  • San Giovanni di Dio Hospital

    Florence, 50124

Other trials in Italy

About this study

Official title: Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

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.

Being tested
Open surgical revascularization, Endovascular revascularization
Keywords
Surgical revascularization, Endovascular revascularization, Amputation, Peripheral artery disease, Critical limb ischemia, claudication, leg pain, leg ulcer, gangrene
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Intermittent Claudication, Leg Ulcer, Gangrene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open surgical revascularizationProcedure or surgery

  • Endovascular revascularizationDevice

    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.

Study groups in NCT02060630
Study groupRoleWhat they receive
Available vein, open surg. revasc.OtherSubjects with an available SSGSV cohort randomized to open surgical revascularization
Receives: Procedure: Open surgical revascularization
Available vein, endovasc. revasc.OtherSubjects with an available SSGSV cohort randomized to endovascular revascularization
Receives: Device: Endovascular revascularization
Alternative conduit, open surg. revasc.OtherSubjects with an alternative conduit cohort randomized to open surgical revascularization
Receives: Procedure: Open surgical revascularization
Alternative conduit, endovasc. revasc.OtherSubjects with an alternative conduit cohort randomized to endovascular revascularization
Receives: Device: Endovascular revascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (44)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion1 Mar 2022
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,843 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02060630
Sponsor's protocol ID
BEST-CLI Trial
Other IDs
1U01HL107407
Acronym
BEST-CLI
Status last verified
Mar 2022
First submitted
6 Feb 2014
Last updated
11 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Lee JY, Parvathinathan G, Liu S, Etemadi A, Stedman MR, Arya S, Chang TI. Efficacy and safety of revascularization in patients with chronic limb-threatening ischemia by kidney function. Am Heart J. 2026 Aug 5:107550. doi: 10.1016/j.ahj.2026.107550. Online ahead of print.

    PubMed 42556521

  • Hicks CW, Farber A, Doros G, Kinlay S, Powell RJ, Strong MB, Rosenfield K, Aridi H, Motaganahalli R, Barleben A, Siracuse JJ, Azene E, Malas M, Conte MS, Zayed M, Menard MT. Atherectomy Is Not Associated With Improved Limb-Based Outcomes Among Patients in the BEST-CLI Trial Undergoing Endovascular Revascularization. JACC Cardiovasc Interv. 2026 Jan 12;19(1):96-107. doi: 10.1016/j.jcin.2025.10.065.

    PubMed 41534992

  • Venermo MA, de Vega M, Houlind K, Siracuse JJ, Doros G, Kiang S, Barshes N, Rosenfield K, Menard MT, Farber A; BEST-CLI haemodynamic working group. Baseline Haemodynamic Measurements and Immediate Change in Parameters after Revascularisation: Ankle Pressure, Ankle Brachial Index, Toe Pressure, and Toe Brachial Index Analysis of the BEST-CLI Participants. Eur J Vasc Endovasc Surg. 2026 Jun;71(6):942-949. doi: 10.1016/j.ejvs.2025.12.042. Epub 2025 Dec 24.

    PubMed 41453560

  • Tan TW, Dansey KD, Farber A, Doros G, Menard MT, Rosenfield K, Conte MS, Venermo M, Kolh P, Strong MB, Singh N. High rates of nonindex limb amputation in the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial. J Vasc Surg. 2026 Mar;83(3):905-913. doi: 10.1016/j.jvs.2025.11.009. Epub 2025 Nov 14.

    PubMed 41242623

  • Alameddine D, Hamouda M, Doros G, Conte MS, Rosenfield K, Strong MB, Menard MT, Farber A, Hamdan A, Malas M, Ochoa Chaar CI. Insulin therapy and outcomes of revascularization procedures for chronic limb-threatening ischemia in the BEST-CLI trial. J Vasc Surg. 2026 Jan;83(1):246-255.e3. doi: 10.1016/j.jvs.2025.08.033. Epub 2025 Aug 29.

    PubMed 40886741

  • Jones DW, Farber A, Armstrong DG, Azene E, Duncan A, Todoran TM, Doros G, Strong MB, Rosenfield K, Conte MS, Menard MT. Characteristics of multidisciplinary limb preservation teams and their impact on outcomes in the BEST-CLI trial. J Vasc Surg. 2026 Feb;83(2):528-538. doi: 10.1016/j.jvs.2025.08.028. Epub 2025 Aug 28.

    PubMed 40885461

  • Alonso A, Huang J, Oro CF, Maaneb de Macedo K, Lotfollahzadeh S, Kalish J, Farber A, King E, Chitalia VC, Siracuse JJ. Factors associated with cancellation of arteriovenous access creations. J Vasc Surg. 2025 Oct;82(4):1477-1484. doi: 10.1016/j.jvs.2025.05.211. Epub 2025 Jun 6.

    PubMed 40484061

  • Siracuse JJ, Kaufman JA, Farber A, Menard MT, Rosenfield K, Conte MS, Schanzer A, Powell RJ, Venermo M, Doros G, Faries P, Strong MB, Dake MD. Antiproliferative endovascular drug technology is associated with fewer major reinterventions after femoropopliteal interventions for chronic limb-threatening ischemia. J Vasc Surg. 2025 Oct;82(4):1375-1382. doi: 10.1016/j.jvs.2025.04.029. Epub 2025 Jun 4.

    PubMed 40464723

  • Ramkumar N, Goodney PP, Moore K, Goodney AJ, Ponukumati AS, Menard M, Farber A, Staiger D. Selecting Treatments for Peripheral Artery Disease: Differences Between Registry and a Randomized Controlled Trial Population. J Surg Res. 2025 Apr;308:286-294. doi: 10.1016/j.jss.2025.02.040. Epub 2025 Mar 25.

    PubMed 40138771

  • Conte MS, Farber A, Barleben A, Chisci E, Doros G, Kashyap VS, Kayssi A, Kolh P, Moreira CC, Nypaver T, Rosenfield K, Rowe VL, Schanzer A, Singh N, Siracuse JJ, Strong MB, Menard MT. Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia. Circ Cardiovasc Interv. 2025 Mar;18(3):e014716. doi: 10.1161/CIRCINTERVENTIONS.124.014716. Epub 2025 Mar 18.

    PubMed 40100950

  • Barleben AR, Patel RJ, Farber A, Menard MT, Venermo M, Creager MA, Reitz KM, Strong M, Rosenfield K, Doros G, Dake M, Chaer RA. An assessment of the BEST-CLI Trial demonstrates that infrainguinal bypass offers a potential advantage in smokers with chronic limb-threatening ischemia. J Vasc Surg. 2025 Jun;81(6):1411-1419.e1. doi: 10.1016/j.jvs.2025.02.015. Epub 2025 Feb 19.

    PubMed 39984143

  • Alonso A, Kobzeva-Herzog AJ, Levin SR, de Macedo KM, Melvin J, Farber A, King EG, Garg K, Shean KE, O'Donnell TFX, Rybin D, Siracuse JJ. Disability and associated outcomes among patients suffering periprocedural strokes after carotid artery stenting. J Vasc Surg. 2025 Jun;81(6):1343-1350. doi: 10.1016/j.jvs.2025.01.223. Epub 2025 Feb 7.

    PubMed 39923916

  • Ulloa JG, Alabi O, McGinigle K, Lane J, Doros G, Menard M, Moreira CC, Judelson DR, Farber A, Conte MS, Rosenfeld K, Hamouda M, Kirksey L, Strong MB, Malas M, Kernodle A, Rowe VL. Outcomes for Hispanic patients undergoing open bypass in BEST-CLI. J Vasc Surg. 2025 Jun;81(6):1420-1429. doi: 10.1016/j.jvs.2025.01.212. Epub 2025 Feb 4.

    PubMed 39914761

  • Alonso A, Kobzeva-Herzog A, Dalton-Petillo S, Haqqani M, Farber A, King EG, Hicks CW, Malas M, Garg K, Osborne N, Simons JP, Siracuse JJ. Evaluating the management of intermittent claudication before and after publication of the Society of Vascular Surgery's Appropriate Use Criteria. J Vasc Surg. 2025 Aug;82(2):526-533.e3. doi: 10.1016/j.jvs.2024.12.133. Epub 2025 Jan 27.

    PubMed 39880293

  • Malas MB, Hamouda M, Farber A, Menard MT, Conte MS, Rosenfield K, Strong MB, Doros G, Powell RJ, Mena-Hurtado C, Gasper W, Schermerhorn ML, Allievi S, Smolderen KG, Dake MD, Rymer JA, Tuttle KR. Outcomes of chronic limb-threatening ischemia revascularization in patients with chronic kidney disease in the BEST-CLI trial. J Vasc Surg. 2025 Apr;81(4):945-956.e3. doi: 10.1016/j.jvs.2024.12.128. Epub 2025 Jan 23.

    PubMed 39846933

Questions about this trial

What is this clinical trial studying?

A study testing Open surgical revascularization and Endovascular revascularization in people with Critical Limb Ischemia, run by Carelon Research at 161 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Canada, New Zealand, Finland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060630, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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