Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia (BEST-CLI)

• ClinicalTrials.gov Identifier: NCT02060630
• Recruitment Status: Completed
• First Posted: February 12, 2014
• Last Update Posted: April 11, 2023
• Sponsor: HealthCore-NERI
• 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; Cardiovascular Systems Inc; 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
• Information provided by (Responsible Party): HealthCore-NERI

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Critical Limb Ischemia	Procedure: Open surgical revascularization; Device: Endovascular revascularization	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1843 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: March 1, 2022
• Actual Study Completion Date: March 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Available vein, open surg. revasc.; Subjects with an available SSGSV cohort randomized to open surgical revascularization	Procedure: Open surgical revascularization
Available vein, endovasc. revasc.; Subjects with an available SSGSV cohort randomized to endovascular revascularization	Device: 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	Procedure: Open surgical revascularization
Alternative conduit, endovasc. revasc.; Subjects with an alternative conduit cohort randomized to endovascular revascularization	Device: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Clinical: Re-intervention and amputation-free survival (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   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
2. Clinical: Re-intervention and amputation-free survival (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   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
3. Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   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
4. Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   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
5. Clinical: Amputation-free survival (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   Time to amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available
6. Clinical: Amputation-free survival (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   Time to amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV
7. Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   Time to death within 30 days of index procedure in subjects with SSGSV available
8. Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   Time to death within 30 days of index procedure in subjects without available SSGSV
9. Clinical: Freedom from Myocardial Infarction (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
   Time to myocardial infarction (MI) in subjects with SSGSV available
10. Clinical: Freedom from Myocardial Infarction (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to myocardial infarction (MI) in subjects without available SSGSV
11. Clinical: Freedom from Stroke (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to stroke in subjects with SSGSV available
12. Clinical: Freedom from Stroke (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to stroke in subjects without available SSGSV
13. Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to re-intervention (major and minor) in index leg in subjects with SSGSV available
14. Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to re-intervention (major and minor) in index leg in subjects without available SSGSV
15. Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Number of re-interventions (major and minor) in per limb salvaged in subjects with SSGSV available
16. Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Number of re-interventions (major and minor) in per limb salvaged in subjects without available SSGSV
17. Clinical: Freedom from hemodynamic failure (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to hemodynamic failure in subjects with SSGSV available
18. Clinical: Freedom from hemodynamic failure (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to hemodynamic failure in subjects without available SSGSV
19. Clinical: Freedom from clinical failure (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects with SSGSV available
20. Clinical: Freedom from clinical failure (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to above ankle amputation, major reintervention, MALE, degradation of WIfI stage or death, whichever occurs first in subjects without available SSGSV
21. Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to resolution of presenting CLI symptoms in the index limb in subjects with SSGSV available
22. Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to resolution of presenting CLI symptoms in the index limb in subjects without available SSGSV
23. Clinical: Freedom from all-cause mortality (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to all-cause mortality in subjects with SSGSV available
24. Clinical: Freedom from all-cause mortality (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Time to all-cause mortality in subjects without available SSGSV
25. Functional: Quality of Life assessment using VasuQoL (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    VasuQOL measurements in subjects with SSGSV available
26. Functional: Quality of Life assessment using VasuQoL (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    VasuQOL measurements in subjects without available SSGSV
27. Functional: Quality of Life assessment using EuroQoL (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    EuroQOL measurements in subjects with SSGSV available
28. Functional: Quality of Life assessment using EuroQoL (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    EuroQOL measurements in subjects without available SSGSV
29. Functional: Function assessment using SF-12, PCS (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Physical Component Summary (PCS) scores in subjects with SSGSV available
30. Functional: Function assessment using SF-12, PCS (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Physical Component Summary (PCS) scores in subjects without available SSGSV
31. Functional: Function assessment using SF-12, MCS (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Mental Component Summary (MCS) scores in subjects with SSGSV available
32. Functional: Function assessment using SF-12, MCS (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Mental Component Summary (MCS) scores in subjects without available SSGSV
33. Functional: Function assessment using SF-12, SF-6D R2 (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Utility Index (SF-6D R2) scores in subjects with SSGSV available
34. Functional: Function assessment using SF-12, SF-6D R2(cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Utility Index (SF-6D R2) scores in subjects without available SSGSV
35. Functional: Numerical rating scale for Pain, Pain Now (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Pain Now in subjects with SSGSV available
36. Functional: Numerical rating scale for Pain, Pain Now (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Pain Now in subjects without available SSGSV
37. Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Usual level of Pain during the last week in subjects with SSGSV available
38. Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Usual level of Pain during the last week in subjects without available SSGSV
39. Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Best level of Pain during the last week in subjects with SSGSV available
40. Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Best level of Pain during the last week in subjects without available SSGSV
41. Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Worst level of Pain during the last week in subjects with SSGSV available
42. Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    Scores for Worst level of Pain during the last week in subjects without available SSGSV
43. Function: Six-minute walk test (cohort 1) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    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
44. Function: Six-minute walk test (cohort 2) [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject ]
    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

Eligibility Criteria

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

Criteria

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:

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.

Contacts and Locations

Locations

United States, Alabama

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, Arizona

Arizona Heart Hospital

Phoenix, Arizona, United States, 85016

University of Arizona - Banner University Medical Center

Tucson, Arizona, United States, 85719

Carondelet Heart & Vascular Institute

Tucson, Arizona, United States, 85745

United States, Arkansas

University of Arkansas for Medical Services

Little Rock, Arkansas, United States, 72205

United States, California

University of California - Irvine

Irvine, California, United States, 92697

San Diego VAMC

La Jolla, California, United States, 92037

UC San Diego Sulpizio Cardiovascular Center

La Jolla, California, United States, 92037

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

Loma Linda VA Medical Center

Loma Linda, California, United States, 92357

VA Long Beach Healthcare System

Long Beach, California, United States, 90822

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

VA Greater Los Angeles

Los Angeles, California, United States, 90073

Keck Medical Center of USC

Los Angeles, California, United States, 90089

UCLA-Gonda Vascular Surgery

Los Angeles, California, United States, 90095

VA Palo Alto Health Care

Palo Alto, California, United States, 94304

Sacramento VA Medical Center

Sacramento, California, United States, 95655

University of California Davis Medical Center

Sacramento, California, United States, 95817

Kaiser Permanente (San Diego)

San Diego, California, United States, 92123

Kaiser Permanente Northern California

San Francisco, California, United States, 94118

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States, 94121

University of California-San Francisco Medical Center

San Francisco, California, United States, 94143

Stanford Hospital

Stanford, California, United States, 94305

Harbor - UCLA Medical Center

Torrance, California, United States, 90509

United States, Colorado

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Denver Health

Denver, Colorado, United States, 80024

Vascular Institute of the Rockies

Denver, Colorado, United States, 80218

Rocky Mountain Regional VA

Denver, Colorado, United States, 80220

United States, Connecticut

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States, 06105

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

West Haven VAMC

West Haven, Connecticut, United States, 06516

United States, District of Columbia

Medstar Washington Hospital Center

Washington, District of Columbia, United States, 20010

GW Medical Faculty Associates, Inc.

Washington, District of Columbia, United States, 20037

United States, Florida

University of Florida (Gainesville)

Gainesville, Florida, United States, 32610

Mount Sinai Miami

Miami Springs, Florida, United States, 33140

Baptist Hospital of Miami

Miami, Florida, United States, 33176

Florida Hospital Ocala

Ocala, Florida, United States, 34471

Tampa General Hospital

Tampa, Florida, United States, 33606

Tampa VAMC

Tampa, Florida, United States, 33612

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30303

Atlanta VA Medical Center

Decatur, Georgia, United States, 30033

United States, Hawaii

Kaiser Foundation Hospital

Honolulu, Hawaii, United States, 96819

United States, Illinois

Central DuPage Hospital (Cadence)

Chicago, Illinois, United States, 60190

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Chicago Medicine

Chicago, Illinois, United States, 60637

Decatur Memorial Hospital

Decatur, Illinois, United States, 62526

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

Northwestern Memorial Hospital

Winfield, Illinois, United States, 601611

United States, Indiana

Indiana University Medical School

Indianapolis, Indiana, United States, 46202

United States, Iowa

Mercy Hospital Medical Center

West Des Moines, Iowa, United States, 50266

United States, Louisiana

Ochsner Medical Center

New Orleans, Louisiana, United States, 70121

University Health System: LSU Health Sciences

Shreveport, Louisiana, United States, 71130

United States, Maine

Maine Medical Center

Portland, Maine, United States, 04102

United States, Maryland

University of Maryland Medical System

Baltimore, Maryland, United States, 21201

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21210

Loyola University Medical Center

Baltimore, Maryland, United States, 21210

MedStar Union Memorial Hospital

Baltimore, Maryland, United States, 21218

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Boston Medical Center

Boston, Massachusetts, United States, 02118

VA Boston Healthcare System

Boston, Massachusetts, United States, 02132

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, United States, 02135

South Shore Hospital

Weymouth, Massachusetts, United States, 02189

University of Massachusetts Medical School

Worcester, Massachusetts, United States, 01655

United States, Michigan

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States, 48105

Michigan Heart/St. Joseph Mercy Ann Arbor Hospital

Ann Arbor, Michigan, United States, 48106

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109

Henry Ford Health System

Detroit, Michigan, United States, 48202

Michigan Vascular Center

Flint, Michigan, United States, 48507

Spectrum Health

Grand Rapids, Michigan, United States, 49503

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

United States, Minnesota

Minneapolis Heart Hospital/Abbott Northwestern Hosp.

Minneapolis, Minnesota, United States, 55407

Minneapolis VAMC

Minneapolis, Minnesota, United States, 55417

Mayo Clinic

Rochester, Minnesota, United States, 55901

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65212

Midwest Aortic Vascular Institute

Kansas City, Missouri, United States, 64116

St. Louis VA Medical Center

Saint Louis, Missouri, United States, 63106

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Hanover, New Hampshire, United States, 03756

United States, New Jersey

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States, 08015

Englewood Hospital and Medical Center

Englewood, New Jersey, United States, 07631

Rutgers New Jersey Medical School

Newark, New Jersey, United States, 07103

Holy Name Medical Center

Teaneck, New Jersey, United States, 07666

United States, New Mexico

New Mexico Heart Institute

Albuquerque, New Mexico, United States, 87102

New Mexico VA Medical Center

Albuquerque, New Mexico, United States, 87108

United States, New York

Albany Medical Center

Albany, New York, United States, 12208

Montefiore Medical Center

Bronx, New York, United States, 10467

VA Western NY Healthcare System

Buffalo, New York, United States, 14215

Mount Sinai Medical Center

New York, New York, United States, 10029

Columbia University Medical Center

New York, New York, United States, 10032

Vascular Health Partners

Queensbury, New York, United States, 12804

University of Rochester Medical Center

Rochester, New York, United States, 14642

Staten Island University Hospital

Staten Island, New York, United States, 10305

Stony Brook Medicine

Stony Brook, New York, United States, 11794-8191

SUNY Upstate Medical University

Syracuse, New York, United States, 13215

Westchester Medical Center

Valhalla, New York, United States, 10595

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Duke University

Durham, North Carolina, United States, 27705

Durham VAMC

Durham, North Carolina, United States, 27705

North Carolina Heart and Vascular Research

Raleigh, North Carolina, United States, 27607

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

University Hospitals of Cleveland/Case Western Reserve University

Cleveland, Ohio, United States, 44106

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44109

The Ohio State University

Columbus, Ohio, United States, 43210

Ohio Health Research Institute

Columbus, Ohio, United States, 43214

University of Toledo Medical Center

Toledo, Ohio, United States, 43615

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

University of Oklahoma College of Medicine at Tulsa

Tulsa, Oklahoma, United States, 74135

United States, Oregon

Providence Heart and Vascular Institute

Portland, Oregon, United States, 97213

Oregon Health and Science University

Portland, Oregon, United States, 97239

Portland VA Medical Center

Portland, Oregon, United States, 97239

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Temple University

Philadelphia, Pennsylvania, United States, 19140

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Pinnacle Health System

Wormleysburg, Pennsylvania, United States, 17043

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02905

The Miriam Hospital/Brown Medical School

Providence, Rhode Island, United States, 02906

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Prisma Health-Upstate (Formerly Greenville Memorial Hospital)

Greenville, South Carolina, United States, 29605

United States, South Dakota

North Central Heart Institute

Sioux Falls, South Dakota, United States, 57108

United States, Tennessee

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States, 37660

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

United States, Texas

Dallas VA Medical Center

Dallas, Texas, United States, 75390

Memorial Hermann Hospital TMC

Houston, Texas, United States, 77030

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Scott and White - Temple

Temple, Texas, United States, 76508

United States, Utah

The University of Utah

Salt Lake City, Utah, United States, 84132

United States, Vermont

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Sentara Vascular Specialists

Norfolk, Virginia, United States, 23507

United States, Washington

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States, 98101

Harborview Medical Center

Seattle, Washington, United States, 98104

Swedish Medical Center

Seattle, Washington, United States, 98122

Providence Sacred Heart Medical Center

Spokane, Washington, United States, 99204

United States, West Virginia

CAMC Clinical Trials Center

Charleston, West Virginia, United States, 25304

United States, Wisconsin

Gundersen Health System

La Crosse, Wisconsin, United States, 54601

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53706

Meriter Wisconsin Heart

Madison, Wisconsin, United States, 53713

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Milwaukee VAMC

Milwaukee, Wisconsin, United States, 53295

Canada, British Columbia

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z1M9

Canada, Manitoba

St. Boniface General Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

Canada, Nova Scotia

Queen Elizabeth II Health Science Center

Halifax, Nova Scotia, Canada, B3H3A7

Canada, Ontario

University of Western Ontario

London, Ontario, Canada, N6A5W9

The Ottawa Hospital

Ottawa, Ontario, Canada, K1Y4E9

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Canada, Quebec

McGill

Montreal, Quebec, Canada, H3A1A1

Jewish General Hostpital

Montreal, Quebec, Canada, H3T 1E2

Chu de Quebec

Quebec City, Quebec, Canada, G1L 3L5

Canada, Saskatchewan

Regina Qu'Appelle

Regina, Saskatchewan, Canada, S4P 0W5

St. Paul's Hospital

Saskatoon, Saskatchewan, Canada, S7M0Z9

Finland

Helsinki University Hospital

Helsinki, Finland, F100029

Italy

San Giovanni di Dio Hospital

Florence, Italy, 50124

New Zealand

Auckland City Hospital

Grafton, Auckland, New Zealand, 1023

Waikato Hospital

Hamilton, Waikato, New Zealand, 3240

Wellington Hospital

Newtown, Wellington, New Zealand, 6021

Sponsors and Collaborators

HealthCore-NERI

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

Cardiovascular Systems Inc

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

Investigators

• Principal Investigator: Matthew Menard, MD; Brigham and Women's Hospital
• Principal Investigator: Alik Farber, MD; Boston University
• Principal Investigator: Kenneth Rosenfield, MD; Massachusetts General Hospital
• Principal Investigator: Mark Cziraky, PharmD, CLS; HealthCore-NERI
• Principal Investigator: Taye Hamza, PhD; HealthCore-NERI

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: HealthCore-NERI
• ClinicalTrials.gov Identifier: NCT02060630
• Other Study ID Numbers: BEST-CLI Trial; 1U01HL107407 ( U.S. NIH Grant/Contract )
• First Posted: February 12, 2014
• Last Update Posted: April 11, 2023
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by HealthCore-NERI:

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

Additional relevant MeSH terms:

Chronic Limb-Threatening Ischemia; Ischemia; Pathologic Processes; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes