Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
BEST-CLI
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
2 other identifiers
interventional
1,843
5 countries
161
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2014
CompletedFirst Posted
Study publicly available on registry
February 12, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedApril 11, 2023
March 1, 2022
7.6 years
February 6, 2014
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
* Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available * Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
Secondary Outcomes (44)
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
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
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
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
Clinical: Amputation-free survival (cohort 1)
Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject
- +39 more secondary outcomes
Study Arms (4)
Available vein, open surg. revasc.
OTHERSubjects with an available SSGSV cohort randomized to open surgical revascularization
Available vein, endovasc. revasc.
OTHERSubjects with an available SSGSV cohort randomized to endovascular revascularization
Alternative conduit, open surg. revasc.
OTHERSubjects with an alternative conduit cohort randomized to open surgical revascularization
Alternative conduit, endovasc. revasc.
OTHERSubjects with an alternative conduit cohort randomized to endovascular revascularization
Interventions
A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.
Eligibility Criteria
You may qualify if:
- Male or female, age 18 years or older.
- Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
- CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
- Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
- Adequate aortoiliac inflow.
- Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
- Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
You may not qualify if:
- Presence of a popliteal aneurysm (\>2 cm) in the index limb.
- Life expectancy of less than 2 years due to reasons other than PAOD.
- Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
- Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
- Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).
- Any of the following procedures performed on the index limb within 3 months prior to enrollment:
- Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
- Infrainguinal bypass with either venous or prosthetic conduit
- Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment
- Current chemotherapy or radiation therapy.
- Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) which would preclude patient participation in angiographic procedures.
- Pregnancy or lactation.
- Administration of an investigational drug for PAD within 30 days of randomization.
- Participation in a clinical trial (except observational studies) within the previous 30 days.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carelon Researchlead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
- Boston Medical Centercollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Abbottcollaborator
- Bard Ltdcollaborator
- Boston Scientific Corporationcollaborator
- Cordis US Corp.collaborator
- Abbott Medical Devicescollaborator
- Canadian Society for Vascular Surgerycollaborator
- Eastern Vascular Societycollaborator
- W.L.Gore & Associatescollaborator
- Midwest Vascular Societycollaborator
- New England Society for Vascular Surgerycollaborator
- Society for Clinical Vascular Surgerycollaborator
- Society for Interventional Radiologycollaborator
- Southern Vascular Societycollaborator
- Society for Vascular Medicinecollaborator
- Society for Vascular Surgerycollaborator
- Vascular and Endovascular Surgery Societycollaborator
- Vascular Interventional Advancescollaborator
- Western Vascular Societycollaborator
Study Sites (161)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
University of Arizona - Banner University Medical Center
Tucson, Arizona, 85719, United States
Carondelet Heart & Vascular Institute
Tucson, Arizona, 85745, United States
University of Arkansas for Medical Services
Little Rock, Arkansas, 72205, United States
University of California - Irvine
Irvine, California, 92697, United States
San Diego VAMC
La Jolla, California, 92037, United States
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Loma Linda VA Medical Center
Loma Linda, California, 92357, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
VA Greater Los Angeles
Los Angeles, California, 90073, United States
Keck Medical Center of USC
Los Angeles, California, 90089, United States
UCLA-Gonda Vascular Surgery
Los Angeles, California, 90095, United States
VA Palo Alto Health Care
Palo Alto, California, 94304, United States
Sacramento VA Medical Center
Sacramento, California, 95655, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanente (San Diego)
San Diego, California, 92123, United States
Kaiser Permanente Northern California
San Francisco, California, 94118, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
University of California-San Francisco Medical Center
San Francisco, California, 94143, United States
Stanford Hospital
Stanford, California, 94305, United States
Harbor - UCLA Medical Center
Torrance, California, 90509, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver Health
Denver, Colorado, 80024, United States
Vascular Institute of the Rockies
Denver, Colorado, 80218, United States
Rocky Mountain Regional VA
Denver, Colorado, 80220, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
West Haven VAMC
West Haven, Connecticut, 06516, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
GW Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, 20037, United States
University of Florida (Gainesville)
Gainesville, Florida, 32610, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Mount Sinai Miami
Miami Springs, Florida, 33140, United States
Florida Hospital Ocala
Ocala, Florida, 34471, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Tampa VAMC
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30303, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Kaiser Foundation Hospital
Honolulu, Hawaii, 96819, United States
Central DuPage Hospital (Cadence)
Chicago, Illinois, 60190, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Northwestern Memorial Hospital
Winfield, Illinois, 601611, United States
Indiana University Medical School
Indianapolis, Indiana, 46202, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, 50266, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
University Health System: LSU Health Sciences
Shreveport, Louisiana, 71130, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21210, United States
Loyola University Medical Center
Baltimore, Maryland, 21210, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
VA Boston Healthcare System
Boston, Massachusetts, 02132, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
South Shore Hospital
Weymouth, Massachusetts, 02189, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Michigan Vascular Center
Flint, Michigan, 48507, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Minneapolis Heart Hospital/Abbott Northwestern Hosp.
Minneapolis, Minnesota, 55407, United States
Minneapolis VAMC
Minneapolis, Minnesota, 55417, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
University of Missouri
Columbia, Missouri, 65212, United States
Midwest Aortic Vascular Institute
Kansas City, Missouri, 64116, United States
St. Louis VA Medical Center
St Louis, Missouri, 63106, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth Hitchcock Medical Center
Hanover, New Hampshire, 03756, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
New Mexico VA Medical Center
Albuquerque, New Mexico, 87108, United States
Albany Medical Center
Albany, New York, 12208, United States
VA Western NY Healthcare System
Buffalo, New York, 14215, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Vascular Health Partners
Queensbury, New York, 12804, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Stony Brook Medicine
Stony Brook, New York, 11794-8191, United States
SUNY Upstate Medical University
Syracuse, New York, 13215, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27705, United States
Durham VAMC
Durham, North Carolina, 27705, United States
North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44109, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
University of Toledo Medical Center
Toledo, Ohio, 43615, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma College of Medicine at Tulsa
Tulsa, Oklahoma, 74135, United States
Providence Heart and Vascular Institute
Portland, Oregon, 97213, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Pinnacle Health System
Wormleysburg, Pennsylvania, 17043, United States
Rhode Island Hospital
Providence, Rhode Island, 02905, United States
The Miriam Hospital/Brown Medical School
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health-Upstate (Formerly Greenville Memorial Hospital)
Greenville, South Carolina, 29605, United States
North Central Heart Institute
Sioux Falls, South Dakota, 57108, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Dallas VA Medical Center
Dallas, Texas, 75390, United States
Memorial Hermann Hospital TMC
Houston, Texas, 77030, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
Scott and White - Temple
Temple, Texas, 76508, United States
The University of Utah
Salt Lake City, Utah, 84132, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53706, United States
Meriter Wisconsin Heart
Madison, Wisconsin, 53713, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Milwaukee VAMC
Milwaukee, Wisconsin, 53295, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, B3H3A7, Canada
University of Western Ontario
London, Ontario, N6A5W9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
McGill
Montreal, Quebec, H3A1A1, Canada
Jewish General Hostpital
Montreal, Quebec, H3T 1E2, Canada
Chu de Quebec
Québec, Quebec, G1L 3L5, Canada
Regina Qu'Appelle
Regina, Saskatchewan, S4P 0W5, Canada
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M0Z9, Canada
Helsinki University Hospital
Helsinki, F100029, Finland
San Giovanni di Dio Hospital
Florence, 50124, Italy
Auckland City Hospital
Grafton, Auckland, 1023, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 3240, New Zealand
Wellington Hospital
Newtown, Wellington Region, 6021, New Zealand
Related Publications (12)
Hicks CW, Farber A, Doros G, Kinlay S, Powell RJ, Strong MB, Rosenfield K, Aridi H, Motaganahalli R, Barleben A, Siracuse JJ, Azene E, Malas M, Conte MS, Zayed M, Menard MT. Atherectomy Is Not Associated With Improved Limb-Based Outcomes Among Patients in the BEST-CLI Trial Undergoing Endovascular Revascularization. JACC Cardiovasc Interv. 2026 Jan 12;19(1):96-107. doi: 10.1016/j.jcin.2025.10.065.
PMID: 41534992DERIVEDVenermo MA, de Vega M, Houlind K, Siracuse JJ, Doros G, Kiang S, Barshes N, Rosenfield K, Menard MT, Farber A; BEST-CLI hemodynamic working group. Baseline Haemodynamic Measurements and Immediate Change in Parameters after Revascularisation: Ankle Pressure, Ankle Brachial Index, Toe Pressure, and Toe Brachial Index Analysis of the BEST-CLI Participants. Eur J Vasc Endovasc Surg. 2025 Dec 24:S1078-5884(25)01311-5. doi: 10.1016/j.ejvs.2025.12.042. Online ahead of print.
PMID: 41453560DERIVEDConte MS, Farber A, Barleben A, Chisci E, Doros G, Kashyap VS, Kayssi A, Kolh P, Moreira CC, Nypaver T, Rosenfield K, Rowe VL, Schanzer A, Singh N, Siracuse JJ, Strong MB, Menard MT. Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia. Circ Cardiovasc Interv. 2025 Mar;18(3):e014716. doi: 10.1161/CIRCINTERVENTIONS.124.014716. Epub 2025 Mar 18.
PMID: 40100950DERIVEDSiracuse JJ, Farber A, Menard MT, Conte MS, Kaufman JA, Jaff M, Kiang SC, Ochoa Chaar CI, Osborne N, Singh N, Tan TW, Guzman RJ, Strong MB, Hamza TH, Doros G, Rosenfield K. Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in the BEST-CLI Trial. J Vasc Surg. 2023 Oct;78(4):1012-1020.e2. doi: 10.1016/j.jvs.2023.05.040. Epub 2023 Jun 14.
PMID: 37318428DERIVEDLevin SR, Farber A, Kobzeva-Herzog A, King EG, Eslami MH, Garg K, Patel VI, Rockman CB, Rybin D, Siracuse JJ. Postoperative disability and one-year outcomes for patients suffering a stroke after carotid endarterectomy. J Vasc Surg. 2023 Aug;78(2):413-422.e1. doi: 10.1016/j.jvs.2023.04.002. Epub 2023 Apr 10.
PMID: 37040850DERIVEDSiracuse JJ, Rowe VL, Menard MT, Rosenfield K, Conte MS, Powell R, Clavijo LC, Giles KA, Hamza TH, Van Over M, Cziraky M, White CJ, Strong MB, Farber A. Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial. J Vasc Surg. 2023 Apr;77(4):1099-1106.e4. doi: 10.1016/j.jvs.2022.11.050. Epub 2022 Nov 23.
PMID: 36435274DERIVEDFarber 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.
PMID: 36342173DERIVEDAlbaghdadi 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.
PMID: 33825577DERIVEDRathakrishnan 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.
PMID: 33314979DERIVEDPowell 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.
PMID: 31010516DERIVEDFarber 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.
PMID: 30683195DERIVEDMenard 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.
PMID: 27402237DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Carelon Research
- PRINCIPAL INVESTIGATOR
Taye Hamza, PhD
Carelon Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2014
First Posted
February 12, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
April 11, 2023
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share