Clinical trial NCT02060630: Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Official title: Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Keywords: Surgical revascularization
Endovascular revascularization
Amputation
Peripheral artery disease
Critical limb ischemia
claudication
leg pain
leg ulcer
gangrene
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Boston Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Abbott
name: Bard Ltd
name: Boston Scientific Corporation
name: Cordis Corporation
name: Abbott Medical Devices
name: Canadian Society for Vascular Surgery
name: Eastern Vascular Society
name: W.L.Gore & Associates
name: Midwest Vascular Society
name: New England Society for Vascular Surgery
name: Society for Clinical Vascular Surgery
name: Society for Interventional Radiology
name: Southern Vascular Society
name: Society for Vascular Medicine
name: Society for Vascular Surgery
name: Vascular and Endovascular Surgery Society
name: Vascular Interventional Advances
name: Western Vascular Society
First posted: 2014-02-12
Enrollment: 1843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
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)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary outcomes:
measure: Clinical: Re-intervention and amputation-free survival (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Re-intervention and amputation-free survival (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Amputation-free survival (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Amputation-free survival (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from Myocardial Infarction (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from Myocardial Infarction (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from Stroke (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from Stroke (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from hemodynamic failure (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from hemodynamic failure (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from clinical failure (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from clinical failure (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from all-cause mortality (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Clinical: Freedom from all-cause mortality (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Quality of Life assessment using VasuQoL (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Quality of Life assessment using VasuQoL (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Quality of Life assessment using EuroQoL (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Quality of Life assessment using EuroQoL (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Function assessment using SF-12, PCS (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Function assessment using SF-12, PCS (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Function assessment using SF-12, MCS (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Function assessment using SF-12, MCS (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Function assessment using SF-12, SF-6D R2(cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Pain Now (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Pain Now (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Function: Six-minute walk test (cohort 1)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
measure: Function: Six-minute walk test (cohort 2)
timeFrame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
city: Tucson
country: United States
facility: University of Arizona - Banner University Medical Center
state: Arizona
city: Tucson
country: United States
facility: Carondelet Heart & Vascular Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Services
state: Arkansas
city: Irvine
country: United States
facility: University of California - Irvine
state: California
city: La Jolla
country: United States
facility: San Diego VAMC
state: California
city: La Jolla
country: United States
facility: UC San Diego Sulpizio Cardiovascular Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda VA Medical Center
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: UCLA-Gonda Vascular Surgery
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care
state: California
city: Sacramento
country: United States
facility: Sacramento VA Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente (San Diego)
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: University of California-San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Denver
country: United States
facility: Vascular Institute of the Rockies
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Regional VA
state: Colorado
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: West Haven
country: United States
facility: West Haven VAMC
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: GW Medical Faculty Associates, Inc.
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida (Gainesville)
state: Florida
city: Miami Springs
country: United States
facility: Mount Sinai Miami
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Ocala
country: United States
facility: Florida Hospital Ocala
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa VAMC
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Foundation Hospital
state: Hawaii
city: Chicago
country: United States
facility: Central DuPage Hospital (Cadence)
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Winfield
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical School
state: Indiana
city: West Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: University Health System: LSU Health Sciences
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Loyola University Medical Center
state: Maryland
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Brighton
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Hospital/Abbott Northwestern Hosp.
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Kansas City
country: United States
facility: Midwest Aortic Vascular Institute
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hanover
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico VA Medical Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: VA Western NY Healthcare System
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Queensbury
country: United States
facility: Vascular Health Partners
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland/Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: University of Oklahoma College of Medicine at Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital/Brown Medical School
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health-Upstate (Formerly Greenville Memorial Hospital)
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital TMC
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Temple
country: United States
facility: Scott and White - Temple
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Madison
country: United States
facility: Meriter Wisconsin Heart
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee VAMC
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Science Center
state: Nova Scotia
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hostpital
state: Quebec
city: Quebec City
country: Canada
facility: Chu de Quebec
state: Quebec
city: Regina
country: Canada
facility: Regina Qu'Appelle
state: Saskatchewan
city: Saskatoon
country: Canada
facility: St. Paul's Hospital
state: Saskatchewan
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Florence
country: Italy
facility: San Giovanni di Dio Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
Study officials:
affiliation: Brigham and Women's Hospital
name: Matthew Menard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Alik Farber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Kenneth Rosenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carelon Research
name: Mark Cziraky, PharmD, CLS
role: PRINCIPAL_INVESTIGATOR
affiliation: Carelon Research
name: Taye Hamza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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