Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
NCT ID: NCT02060630
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1843 participants
INTERVENTIONAL
2014-08-31
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Available vein, open surg. revasc.
Subjects with an available SSGSV cohort randomized to open surgical revascularization
Open surgical revascularization
Available vein, endovasc. revasc.
Subjects with an available SSGSV cohort randomized to endovascular revascularization
Endovascular 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.
Alternative conduit, open surg. revasc.
Subjects with an alternative conduit cohort randomized to open surgical revascularization
Open surgical revascularization
Alternative conduit, endovasc. revasc.
Subjects with an alternative conduit cohort randomized to endovascular revascularization
Endovascular 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.
Interventions
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Open surgical revascularization
Endovascular 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Boston Medical Center
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Abbott
INDUSTRY
Bard Ltd
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Cordis Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Canadian Society for Vascular Surgery
UNKNOWN
Eastern Vascular Society
UNKNOWN
W.L.Gore & Associates
INDUSTRY
Midwest Vascular Society
UNKNOWN
New England Society for Vascular Surgery
UNKNOWN
Society for Clinical Vascular Surgery
UNKNOWN
Society for Interventional Radiology
UNKNOWN
Southern Vascular Society
UNKNOWN
Society for Vascular Medicine
UNKNOWN
Society for Vascular Surgery
OTHER
Vascular and Endovascular Surgery Society
UNKNOWN
Vascular Interventional Advances
UNKNOWN
Western Vascular Society
UNKNOWN
Carelon Research
OTHER
Responsible Party
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Principal Investigators
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Matthew Menard, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Alik Farber, MD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Kenneth Rosenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Mark Cziraky, PharmD, CLS
Role: PRINCIPAL_INVESTIGATOR
Carelon Research
Taye Hamza, PhD
Role: PRINCIPAL_INVESTIGATOR
Carelon Research
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Heart Hospital
Phoenix, Arizona, United States
University of Arizona - Banner University Medical Center
Tucson, Arizona, United States
Carondelet Heart & Vascular Institute
Tucson, Arizona, United States
University of Arkansas for Medical Services
Little Rock, Arkansas, United States
University of California - Irvine
Irvine, California, United States
San Diego VAMC
La Jolla, California, United States
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Loma Linda VA Medical Center
Loma Linda, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
VA Greater Los Angeles
Los Angeles, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
UCLA-Gonda Vascular Surgery
Los Angeles, California, United States
VA Palo Alto Health Care
Palo Alto, California, United States
Sacramento VA Medical Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Kaiser Permanente (San Diego)
San Diego, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
University of California-San Francisco Medical Center
San Francisco, California, United States
Stanford Hospital
Stanford, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Health
Denver, Colorado, United States
Vascular Institute of the Rockies
Denver, Colorado, United States
Rocky Mountain Regional VA
Denver, Colorado, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
West Haven VAMC
West Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
GW Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, United States
University of Florida (Gainesville)
Gainesville, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Mount Sinai Miami
Miami Springs, Florida, United States
Florida Hospital Ocala
Ocala, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Tampa VAMC
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Kaiser Foundation Hospital
Honolulu, Hawaii, United States
Central DuPage Hospital (Cadence)
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Northwestern Memorial Hospital
Winfield, Illinois, United States
Indiana University Medical School
Indianapolis, Indiana, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
University Health System: LSU Health Sciences
Shreveport, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Loyola University Medical Center
Baltimore, Maryland, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
VA Boston Healthcare System
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
South Shore Hospital
Weymouth, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
Ann Arbor, Michigan, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan Vascular Center
Flint, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Hospital/Abbott Northwestern Hosp.
Minneapolis, Minnesota, United States
Minneapolis VAMC
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Midwest Aortic Vascular Institute
Kansas City, Missouri, United States
St. Louis VA Medical Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Hanover, New Hampshire, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
New Mexico VA Medical Center
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
VA Western NY Healthcare System
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Vascular Health Partners
Queensbury, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Durham VAMC
Durham, North Carolina, United States
North Carolina Heart and Vascular Research
Raleigh, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Oklahoma College of Medicine at Tulsa
Tulsa, Oklahoma, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pinnacle Health System
Wormleysburg, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital/Brown Medical School
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health-Upstate (Formerly Greenville Memorial Hospital)
Greenville, South Carolina, United States
North Central Heart Institute
Sioux Falls, South Dakota, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Dallas VA Medical Center
Dallas, Texas, United States
Memorial Hermann Hospital TMC
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Scott and White - Temple
Temple, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
CAMC Clinical Trials Center
Charleston, West Virginia, United States
Gundersen Health System
La Crosse, Wisconsin, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Meriter Wisconsin Heart
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Milwaukee VAMC
Milwaukee, Wisconsin, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, Canada
University of Western Ontario
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
McGill
Montreal, Quebec, Canada
Jewish General Hostpital
Montreal, Quebec, Canada
Chu de Quebec
Québec, Quebec, Canada
Regina Qu'Appelle
Regina, Saskatchewan, Canada
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
Helsinki University Hospital
Helsinki, , Finland
San Giovanni di Dio Hospital
Florence, , Italy
Auckland City Hospital
Grafton, Auckland, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Wellington Hospital
Newtown, Wellington Region, New Zealand
Countries
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References
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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.
Siracuse JJ, Farber A, Menard MT, Conte MS, Kaufman JA, Jaff M, Kiang SC, Ochoa Chaar CI, Osborne N, Singh N, Tan TW, Guzman RJ, Strong MB, Hamza TH, Doros G, Rosenfield K. Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in the BEST-CLI Trial. J Vasc Surg. 2023 Oct;78(4):1012-1020.e2. doi: 10.1016/j.jvs.2023.05.040. Epub 2023 Jun 14.
Levin SR, Farber A, Kobzeva-Herzog A, King EG, Eslami MH, Garg K, Patel VI, Rockman CB, Rybin D, Siracuse JJ. Postoperative disability and one-year outcomes for patients suffering a stroke after carotid endarterectomy. J Vasc Surg. 2023 Aug;78(2):413-422.e1. doi: 10.1016/j.jvs.2023.04.002. Epub 2023 Apr 10.
Siracuse JJ, Rowe VL, Menard MT, Rosenfield K, Conte MS, Powell R, Clavijo LC, Giles KA, Hamza TH, Van Over M, Cziraky M, White CJ, Strong MB, Farber A. Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial. J Vasc Surg. 2023 Apr;77(4):1099-1106.e4. doi: 10.1016/j.jvs.2022.11.050. Epub 2022 Nov 23.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BEST-CLI Trial
Identifier Type: -
Identifier Source: org_study_id
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