MedPath

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

Not Applicable
Completed
Conditions
Critical Limb Ischemia
Interventions
Device: Endovascular revascularization
Procedure: Open surgical revascularization
Registration Number
NCT02060630
Lead Sponsor
Carelon Research
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1843
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Available vein, endovasc. revasc.Endovascular revascularizationSubjects with an available SSGSV cohort randomized to endovascular revascularization
Alternative conduit, open surg. revasc.Open surgical revascularizationSubjects with an alternative conduit cohort randomized to open surgical revascularization
Available vein, open surg. revasc.Open surgical revascularizationSubjects with an available SSGSV cohort randomized to open surgical revascularization
Alternative conduit, endovasc. revasc.Endovascular revascularizationSubjects with an alternative conduit cohort randomized to endovascular revascularization
Primary Outcome Measures
NameTimeMethod
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)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
NameTimeMethod
Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)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

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

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

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

Clinical: Freedom from Myocardial Infarction (cohort 1)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

Clinical: Freedom from Stroke (cohort 2)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

Clinical: Freedom from hemodynamic failure (cohort 1)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

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

Clinical: Freedom from clinical failure (cohort 1)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

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

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

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

Clinical: Freedom from clinical failure (cohort 2)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

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

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

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

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

Clinical: Amputation-free survival (cohort 1)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

Clinical: Amputation-free survival (cohort 2)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

Clinical: Freedom from Myocardial Infarction (cohort 2)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

Clinical: Freedom from Stroke (cohort 1)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

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

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

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

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

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

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

Clinical: Freedom from hemodynamic failure (cohort 2)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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Function: Six-minute walk test (cohort 2)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

Function: Six-minute walk test (cohort 1)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

Trial Locations

Locations (160)

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

Florida Hospital Ocala

🇺🇸

Ocala, Florida, United States

West Haven VAMC

🇺🇸

West Haven, Connecticut, United States

Northwestern Memorial Hospital

🇺🇸

Winfield, Illinois, United States

Mercy Hospital Medical Center

🇺🇸

West Des Moines, Iowa, United States

Medstar Washington Hospital Center

🇺🇸

Washington, District of Columbia, United States

Central DuPage Hospital (Cadence)

🇺🇸

Chicago, Illinois, United States

GW Medical Faculty Associates, Inc.

🇺🇸

Washington, District of Columbia, United States

Staten Island University Hospital

🇺🇸

Staten Island, New York, United States

William Beaumont Hospital

🇺🇸

Royal Oak, Michigan, United States

Deborah Heart and Lung Center

🇺🇸

Browns Mills, New Jersey, United States

Johns Hopkins Hospital

🇺🇸

Baltimore, Maryland, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

University of Chicago Medicine

🇺🇸

Chicago, Illinois, United States

University Health System: LSU Health Sciences

🇺🇸

Shreveport, Louisiana, United States

St. Louis VA Medical Center

🇺🇸

Saint Louis, Missouri, United States

University of Missouri

🇺🇸

Columbia, Missouri, United States

VA Western NY Healthcare System

🇺🇸

Buffalo, New York, United States

Vascular Health Partners

🇺🇸

Queensbury, New York, United States

North Carolina Heart and Vascular Research

🇺🇸

Raleigh, North Carolina, United States

Mount Sinai Medical Center

🇺🇸

New York, New York, United States

CAMC Clinical Trials Center

🇺🇸

Charleston, West Virginia, United States

Columbia University Medical Center

🇺🇸

New York, New York, United States

Albany Medical Center

🇺🇸

Albany, New York, United States

Wellmont Holston Valley Medical Center

🇺🇸

Kingsport, Tennessee, United States

University of Tennessee Medical Center

🇺🇸

Knoxville, Tennessee, United States

University of Toledo Medical Center

🇺🇸

Toledo, Ohio, United States

Sentara Vascular Specialists

🇺🇸

Norfolk, Virginia, United States

Memorial Hermann Hospital TMC

🇺🇸

Houston, Texas, United States

Michael E. DeBakey VA Medical Center

🇺🇸

Houston, Texas, United States

North Central Heart Institute

🇺🇸

Sioux Falls, South Dakota, United States

Prisma Health-Upstate (Formerly Greenville Memorial Hospital)

🇺🇸

Greenville, South Carolina, United States

University of Vermont Medical Center

🇺🇸

Burlington, Vermont, United States

Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

St. Paul's Hospital

🇨🇦

Saskatoon, Saskatchewan, Canada

Harborview Medical Center

🇺🇸

Seattle, Washington, United States

Baptist Hospital of Miami

🇺🇸

Miami, Florida, United States

Indiana University Medical School

🇺🇸

Indianapolis, Indiana, United States

Duke University

🇺🇸

Durham, North Carolina, United States

Durham VAMC

🇺🇸

Durham, North Carolina, United States

The University of Utah

🇺🇸

Salt Lake City, Utah, 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

McGill

🇨🇦

Montreal, Quebec, Canada

Jewish General Hostpital

🇨🇦

Montreal, Quebec, Canada

Minneapolis VAMC

🇺🇸

Minneapolis, Minnesota, United States

Minneapolis Heart Hospital/Abbott Northwestern Hosp.

🇺🇸

Minneapolis, Minnesota, United States

MedStar Union Memorial Hospital

🇺🇸

Baltimore, Maryland, United States

Maine Medical Center

🇺🇸

Portland, Maine, United States

University of Arizona - Banner University Medical Center

🇺🇸

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

Loma Linda VA Medical Center

🇺🇸

Loma Linda, California, United States

UC San Diego Sulpizio Cardiovascular Center

🇺🇸

La Jolla, California, United States

VA Long Beach Healthcare System

🇺🇸

Long Beach, California, United States

Loma Linda University Medical Center

🇺🇸

Loma Linda, 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

Kaiser Permanente (San Diego)

🇺🇸

San Diego, California, United States

Kaiser Permanente Northern California

🇺🇸

San Francisco, California, United States

Stanford Hospital

🇺🇸

Stanford, California, United States

Harbor - UCLA Medical Center

🇺🇸

Torrance, California, United States

St. Francis Hospital and Medical Center

🇺🇸

Hartford, Connecticut, United States

Loyola University Medical Center

🇺🇸

Baltimore, Maryland, United States

Michigan Vascular Center

🇺🇸

Flint, Michigan, United States

University Hospitals of Cleveland/Case Western Reserve University

🇺🇸

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

🇺🇸

Pittsburgh, Pennsylvania, United States

Pinnacle Health System

🇺🇸

Wormleysburg, Pennsylvania, United States

Temple University

🇺🇸

Philadelphia, Pennsylvania, United States

Swedish Medical Center

🇺🇸

Seattle, Washington, United States

Regina Qu'Appelle

🇨🇦

Regina, Saskatchewan, Canada

Auckland City Hospital

🇳🇿

Grafton, Auckland, New Zealand

Waikato Hospital

🇳🇿

Hamilton, Waikato, New Zealand

The University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Arizona Heart Hospital

🇺🇸

Phoenix, Arizona, 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

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

Portland VA Medical Center

🇺🇸

Portland, Oregon, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

Tampa VAMC

🇺🇸

Tampa, Florida, United States

Tampa General Hospital

🇺🇸

Tampa, Florida, United States

Medical College of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

Milwaukee VAMC

🇺🇸

Milwaukee, Wisconsin, United States

Atlanta VA Medical Center

🇺🇸

Decatur, Georgia, United States

Southern Illinois University School of Medicine

🇺🇸

Springfield, Illinois, United States

Decatur Memorial Hospital

🇺🇸

Decatur, Illinois, United States

SUNY Upstate Medical University

🇺🇸

Syracuse, New York, United States

Stony Brook Medicine

🇺🇸

Stony Brook, New York, United States

Westchester Medical Center

🇺🇸

Valhalla, New York, United States

Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

The Ohio State University

🇺🇸

Columbus, Ohio, United States

University of Oklahoma College of Medicine at Tulsa

🇺🇸

Tulsa, Oklahoma, United States

Allegheny General Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

The Miriam Hospital/Brown Medical School

🇺🇸

Providence, Rhode Island, United States

Dallas VA Medical Center

🇺🇸

Dallas, Texas, United States

Scott and White - Temple

🇺🇸

Temple, Texas, United States

Inova Fairfax Hospital

🇺🇸

Falls Church, Virginia, United States

Benaroya Research Institute at Virginia Mason

🇺🇸

Seattle, Washington, United States

Providence Sacred Heart Medical Center

🇺🇸

Spokane, Washington, United States

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Penn State Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Ohio Health Research Institute

🇺🇸

Columbus, Ohio, United States

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

St. Boniface General Hospital

🇨🇦

Winnipeg, Manitoba, Canada

University of California Davis Medical Center

🇺🇸

Sacramento, California, United States

Sacramento VA Medical Center

🇺🇸

Sacramento, California, United States

Ochsner Medical Center

🇺🇸

New Orleans, Louisiana, United States

Yale-New Haven Hospital

🇺🇸

New Haven, Connecticut, 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

Midwest Aortic Vascular Institute

🇺🇸

Kansas City, Missouri, United States

University of North Carolina

🇺🇸

Chapel Hill, North Carolina, United States

Wake Forest Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

University of Maryland Medical System

🇺🇸

Baltimore, Maryland, United States

Sunnybrook Health Sciences Centre

🇨🇦

Toronto, Ontario, Canada

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Steward St. Elizabeth's Medical Center

🇺🇸

Brighton, Massachusetts, United States

Providence Heart and Vascular Institute

🇺🇸

Portland, Oregon, United States

San Giovanni di Dio Hospital

🇮🇹

Florence, Italy

Wellington Hospital

🇳🇿

Newtown, Wellington, New Zealand

Vancouver General Hospital

🇨🇦

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Science Center

🇨🇦

Halifax, Nova Scotia, Canada

Mount Sinai Miami

🇺🇸

Miami Springs, Florida, United States

South Shore Hospital

🇺🇸

Weymouth, Massachusetts, United States

Dartmouth Hitchcock Medical Center

🇺🇸

Hanover, New Hampshire, United States

Englewood Hospital and Medical Center

🇺🇸

Englewood, New Jersey, United States

The Ottawa Hospital

🇨🇦

Ottawa, Ontario, Canada

Chu de Quebec

🇨🇦

Quebec City, Quebec, Canada

Helsinki University Hospital

🇫🇮

Helsinki, Finland

VA Boston Healthcare System

🇺🇸

Boston, Massachusetts, United States

University of Massachusetts Medical School

🇺🇸

Worcester, Massachusetts, United States

University of Western Ontario

🇨🇦

London, Ontario, Canada

Rutgers New Jersey Medical School

🇺🇸

Newark, New Jersey, United States

Spectrum Health

🇺🇸

Grand Rapids, Michigan, United States

Holy Name Medical Center

🇺🇸

Teaneck, New Jersey, United States

Gundersen Health System

🇺🇸

La Crosse, Wisconsin, United States

University of Florida (Gainesville)

🇺🇸

Gainesville, Florida, United States

Kaiser Foundation Hospital

🇺🇸

Honolulu, Hawaii, United States

New Mexico Heart Institute

🇺🇸

Albuquerque, New Mexico, United States

New Mexico VA Medical Center

🇺🇸

Albuquerque, New Mexico, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

University of Wisconsin-Madison

🇺🇸

Madison, Wisconsin, United States

Meriter Wisconsin Heart

🇺🇸

Madison, Wisconsin, United States

Carondelet Heart & Vascular Institute

🇺🇸

Tucson, Arizona, United States

VA Palo Alto Health Care

🇺🇸

Palo Alto, California, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

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