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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by New England Research Institutes
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT02060630
First received: February 6, 2014
Last updated: June 20, 2017
Last verified: May 2017
  Purpose
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 Intervention
Critical Limb Ischemia Procedure: Open surgical revascularization Device: Endovascular revascularization

Study Type: Interventional
Study Design: 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

Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]

Secondary Outcome Measures:
  • Time to re-intervention of the index leg, amputation of the index leg, or death, whichever occurs first in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to re-intervention of the index leg, amputation of the index leg, or death, whichever occurs first in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Number of re-interventions in the index leg in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Number of re-interventions in the index leg in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to all-cause mortality in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Time to all-cause mortality in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Change in VascuQoL score in subjects with SSGSV available [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Change in VascuQoL score in subjects without available SSGSV [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Change in EuroQoL EQ-5D score in subjects with SSGSV available [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Change in EuroQoL EQ-5D score in subjects without available SSGSV [ Time Frame: 30 days post-procedure, 3 months, 12 months, 24 months, 36 months, and 48 months ]
  • Treatment associated costs in subjects with SSGSV available [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Treatment associated costs in subjects without available SSGSV [ Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 50 months per subject ]
  • Major adverse cardiovascular events in subjects with SSGSV available [ Time Frame: 30 days post-procedure ]
  • Major adverse cardiovascular events in subjects without available SSGSV [ Time Frame: 30 days post-procedure ]
  • Proportion of subjects with at least one peri-operative complication in subjects with SSGSV available [ Time Frame: 30 days post-procedure ]
  • Proportion of subjects with at least one peri-operative complication in subjects without available SSGSV [ Time Frame: 30 days post-procedure ]

Estimated Enrollment: 2100
Study Start Date: August 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060630

Contacts
Contact: Flora S Siami, MPH 617-972-3317 ssiami@neriscience.com

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Marc Passman, MD       mpassman@uabmc.edu   
Principal Investigator: Marc Passman, MD         
United States, Arizona
Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Venkatesh Ramaiah, MD       vramaiah@abrazohealth.com   
Principal Investigator: Venkatesh Ramaiah, MD         
Carondelet Heart & Vascular Institute Recruiting
Tucson, Arizona, United States, 85745
Contact: Scott Berman, MD       sberman@azvasc.com   
Principal Investigator: Scott Berman, Berman         
United States, Arkansas
University of Arkansas for Medical Services Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Matthew Smeds, MD       MRSmeds@uams.edu   
Principal Investigator: Matthew Smeds, MD         
United States, California
University of California - Irvine Recruiting
Irvine, California, United States, 92697
Contact: Nii-Kabu Kabutey, MD       nkabutey@uci.edu   
Principal Investigator: Nii-Kabu Kabutey, MD         
San Diego VAMC Recruiting
La Jolla, California, United States, 92037
Contact: John Lane, MD       J1lane@ucsd.edu   
Principal Investigator: John Lane, MD         
UC San Diego Sulpizio Cardiovascular Center Recruiting
La Jolla, California, United States, 92037
Contact: John Lane, MD       J1lane@ucsd.edu   
Principal Investigator: John Lane, MD         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Ahmed Abou-Zamzam, MD       azamzam@llu.edu   
Principal Investigator: Ahmed Abou-Zamzam, MD         
Loma Linda VA Medical Center Recruiting
Loma Linda, California, United States, 92357
Contact: Christian Bianchi, MD       christian.bianchi@va.gov   
Principal Investigator: Christian Bianchi, MD         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Kaushal Patel, MD       kevin.r.patel@kp.org   
Principal Investigator: Kaushal Patel, MD         
Cedars-Sinai Heart Institute Withdrawn
Los Angeles, California, United States, 90048
VA Greater Los Angeles Recruiting
Los Angeles, California, United States, 90073
Contact: Hugh Gelabert, MD       hgelabert@mednet.ucla.edu   
Principal Investigator: Hugh Gelabert, MD         
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90089
Contact: Vincent Rowe, MD       vincent.rowe@med.usc.edu   
Principal Investigator: Vincent Rowe, MD         
UCLA-Gonda Vascular Surgery Recruiting
Los Angeles, California, United States, 90095
Contact: Peter Lawrence, MD       pflawrence@mednet.ucla.edu   
Principal Investigator: Peter Lawrence, MD         
St. Joseph Hospital Withdrawn
Orange, California, United States, 92865
VA Palo Alto Health Care Recruiting
Palo Alto, California, United States, 94304
Contact: Oliver Aalami, MD       aalami@stanford.edu   
Principal Investigator: Oliver Aalami, MD         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: William Pevec, MD       wcpevec@ucdavis.edu   
Principal Investigator: William Pevec, MD         
Kaiser Permanente (San Diego) Recruiting
San Diego, California, United States, 92120
Contact: Robert Hye, MD       robert.j.hye@kp.org   
Principal Investigator: Robert Hye, MD         
Kaiser Permanente Northern California Recruiting
San Francisco, California, United States, 94118
Contact: Robert Chang, MD       Robert.W.Chang@kp.org   
Principal Investigator: Robert Chang, MD         
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Warren Gasper, MD       warren.gasper@ucsf.edu   
Principal Investigator: Warren Gasper, MD         
University of California-San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Jade Hiramoto, MD       Jade.hiramoto@ucsfmedctr.org   
Principal Investigator: Jade Hiramoto, MD         
Stanford Hospital Recruiting
Stanford, California, United States, 94305
Contact: Venita Chandra, MD       vchandra@stanford.edu   
Principal Investigator: Venita Chandra, MD         
Harbor - UCLA Medical Center Recruiting
Torrance, California, United States, 90509
Contact: Rodney White, MD       rawhite@ucla.edu   
Principal Investigator: Rodney White, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Kevin Rogers, MD, MSc       kevin.rogers@ucdenver.edu   
Principal Investigator: Kevin Rogers, MD, MSc         
Denver VA Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Ehrin Armstrong, MD       Ehrin.armstrong@ucdenver.edu   
Principal Investigator: Ehrin Armstrong, MD         
United States, Connecticut
St. Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Scott Fecteau, MD       sfecteau@stfranciscare.org   
Principal Investigator: Scott Fecteau, MD         
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Carlos Mena-Hurtado, MD       carlos.mena-hurtado@yale.edu   
Principal Investigator: Carlos Mena-Hurtado, MD         
West Haven VAMC Recruiting
West Haven, Connecticut, United States, 06516
Contact: Steven Pfau, MD       steven.pfau@va.gov   
Principal Investigator: Steven Pfau, MD         
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Nelson Bernardo, MD       nelson.l.bernardo@medstar.net   
Principal Investigator: Nelson Bernardo, MD         
GW Medical Faculty Associates, Inc. Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Robyn Macsata, MD       robyn@macsata.com   
Principal Investigator: Robyn Macsata, MD         
United States, Florida
University of Florida (Gainesville) Recruiting
Gainesville, Florida, United States, 32610
Contact: Kristina Giles, MD       kristina.giles@surgery.ufl.edu   
Principal Investigator: Kristina Giles, MD         
Mount Sinai Miami Recruiting
Miami Springs, Florida, United States, 33140
Contact: Robert Beasley, MD       bbeaz@aol.com   
Principal Investigator: Robert Beasley, MD         
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: James Benenati, MD       jamesb@baptisthealth.net   
Principal Investigator: James Benenati, MD         
Munroe Regional Medical Center Recruiting
Ocala, Florida, United States, 34471
Contact: Gregory von Mering, MD       gvonmering@icloud.com   
Principal Investigator: Gregory Von Mering, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Paul Armstrong, MD       parmstro@health.usf.edu   
Principal Investigator: Paul Armstrong, MD         
Tampa VAMC Recruiting
Tampa, Florida, United States, 33612
Contact: Peter Nelson, MD       peter.nelson@va.gov   
Principal Investigator: Peter Nelson, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Khusrow Niazi, MD       kniazi@emory.edu   
Principal Investigator: Khusrow Niazi, MD         
Piedmont Hospital Withdrawn
Atlanta, Georgia, United States, 30309
United States, Hawaii
Kaiser Foundation Hospital Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Peter Schneider, MD       peterschneidermd@aol.com   
Principal Investigator: Peter Schneider, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark Eskandari, MD       meskanda@nmh.org   
Principal Investigator: Mark Eskandari, MD         
Rush University Medical Center Terminated
Chicago, Illinois, United States, 60612
University of Chicago Medicine Terminated
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Jeffrey Trachtenberg, MD       jefftrach@aol.com   
Principal Investigator: Jeffrey Trachtenberg, MD         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Kim Hodgson, MD       khodgson@siumed.edu   
Principal Investigator: Kim Hodgson, MD         
Cadence Health Recruiting
Winfield, Illinois, United States, 60190
Contact: Michael Verta, MD       michael.verta@cadencehealth.org   
Principal Investigator: Michael Verta, MD         
United States, Indiana
Indiana University Medical School Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Raghu Motaganahalli, MD       rmotagan@iupui.edu   
Principal Investigator: Raghu Motaganahalli, MD         
The Heart Center of Lake County Withdrawn
Merrillville, Indiana, United States, 46410
United States, Iowa
Midwest Cardiovascular Research Foundation Withdrawn
Davenport, Iowa, United States, 52803
Mercy Hospital Medical Center Recruiting
West Des Moines, Iowa, United States, 50266
Contact: David McAllister, MD       dmcallister@iowaheart.com   
Principal Investigator: David McAllister, MD         
United States, Louisiana
Baton Rouge General Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70806
Contact: Joseph Griffin, MD       jgriffin@brvsc.com   
Principal Investigator: Joseph Griffin, MD         
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: J. Stephen Jenkins, MD       sjenkins@ochsner.org   
Principal Investigator: J. Stephen Jenkins, MD         
University Health System: LSU Health Sciences Active, not recruiting
Shreveport, Louisiana, United States, 71130
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Elizabeth Blazick, MD       eblazick@mmc.org   
Principal Investigator: Elizabeth Blazick, MD         
United States, Maryland
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Robert Crawford, MD       rcrawford@smail.umaryland.edu   
Principal Investigator: Robert Crawford, MD         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21210
Contact: Ying Wei Lum, MD       ylum@jhmi.edu   
Principal Investigator: Ying Wei Lum, MD         
United States, Massachusetts
Tufts Medical Center Withdrawn
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Glenn LaMuraglia, MD       GLAMURAGLIA@mgh.harvard.edu   
Principal Investigator: Glenn LaMuraglia, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael Belkin, MD       mbelkin@partners.org   
Principal Investigator: Michael Belkin, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jeffrey Kalish, MD       jeffrey.kalish@bmc.org   
Principal Investigator: Jeffrey Kalish, MD         
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02132
Contact: Scott Kinlay, MD       Scott.kinlay@va.gov   
Principal Investigator: Scott Kinlay, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Allen Hamdan, MD       ahamdan@bidmc.harvard.edu   
Principal Investigator: Allen Hamdan, MD         
Steward St. Elizabeth's Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Frank Pomposelli, MD       Frank.pomposelli@steward.org   
Principal Investigator: Frank Pomposelli, MD         
South Shore Hospital Recruiting
Weymouth, Massachusetts, United States, 02189
Contact: Marcus Semel, MD       msemel1@partners.org   
Principal Investigator: Marcus Semel, MD         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Andres Schanzer, MD       Andres.Schanzer@umassmemorial.org   
Principal Investigator: Andres Schanzer, MD         
United States, Michigan
Michigan Heart/St. Joseph Mercy Ann Arbor Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Brian Halloran, MD       brian.halloran@stjoeshealth.org   
Principal Investigator: Brian Halloran, MD         
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Peter Henke, MD       henke@umich.edu   
Principal Investigator: Peter Henke, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Timothy Nypaver, MD       tnypaver1@hfhs.org   
Principal Investigator: Timothy Nypaver, MD         
Michigan Vascular Center Recruiting
Flint, Michigan, United States, 48507
Contact: Robert Molnar, MD       rmolnar8@att.net   
Principal Investigator: Robert Molnar, MD         
William Beaumont Hospital Terminated
Royal Oak, Michigan, United States, 48073
Metro Health Hospital Withdrawn
Wyoming, Michigan, United States, 49519
United States, Minnesota
Minneapolis Heart Hospital/Abbott Northwestern Hosp. Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jason Alexander, MD       Jason.Alexander@allina.com   
Principal Investigator: Jason Alexander, MD         
Minneapolis VAMC Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Daniel Ihnat, MD       Daniel.Ihnat@va.gov   
Principal Investigator: Daniel Ihnat, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Manju Kalra, MBBS    507-284-3407    kalra.manju@mayo.edu   
Principal Investigator: Manju Kalra, MBBS         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Todd Vogel, MD       vogeltr@health.missouri.edu   
Principal Investigator: Todd Vogel, MD         
Midwest Aortic Vascular Institute Recruiting
Kansas City, Missouri, United States, 64116
Contact: Scott Kujath, MD       Skujath@mavi.life   
Principal Investigator: Scott Kujath, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: G. Matthew Longo, MD       glongo@unmc.edu   
Principal Investigator: G. Matthew Longo, MD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Hanover, New Hampshire, United States, 03756
Contact: Philip Goodney, MD       philip.p.goodney@hitchcock.org   
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Richard Kovach, MD       kovachr@deborah.org   
Principal Investigator: Richard Kovach, MD         
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Thomas Bernik, MD       thomas.bernik@ehmchealth.org   
Principal Investigator: Thomas Bernik, MD         
Hunterdon Medical Center Withdrawn
Flemington, New Jersey, United States, 08822
Rutgers New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Timothy Wu, MD       tw394@njms.rutgers.edu   
Principal Investigator: Timothy Wu, MD         
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: John Rundback, MD       jrundback@airsllp.com   
Principal Investigator: John Rundback, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Stephen Henao, MD       steveh@nmhi.com   
Principal Investigator: Stephen Henao, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: R. Clement Darling, III, MD       darling@albanyvascular.com   
Principal Investigator: R. Clement Darling, III, MD         
VA Western NY Healthcare System Recruiting
Buffalo, New York, United States, 14215
Contact: Hasan Dosluoglu, MD       Hasan.dosluoglu@va.gov   
Principal Investigator: Hasan Dosluoglu, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Ageliki Vouyouka, MD       ageliki.vouyouka@mountsinai.org   
Principal Investigator: Ageliki Vouyouka, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Danielle Bajakian, MD    212-305-8665    db2766@cumc.columbia.edu   
Principal Investigator: Danielle Bajakian, MD         
Lenox Hill Hospital Withdrawn
New York, New York, United States, 10075
Vascular Health Partners Recruiting
Queensbury, New York, United States, 12804
Contact: Manish Mehta, MD, MPH       mmehta@communitycare.com   
Principal Investigator: Manish Mehta, MD, MPH         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Michael Stoner, MD    585-275-6772    Michael_Stoner@urmc.rochester.edu   
Principal Investigator: Michael Stoner, MD         
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Jonathan Schor, MD       jschor@nshs.edu   
Principal Investigator: Jonathan Schor, MD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13215
Contact: Palma Shaw, MD    315-464-6241    shawp@upstate.edu   
Principal Investigator: Palma Shaw, MD         
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Evan Lipsitz, MD       elipsitz@montefiore.org   
Westchester Medical Center Recruiting
Valhalla, New York, United States, 10595
Contact: Igor Laskowski, MD       Igor.Laskowski@wmchealth.org   
Principal Investigator: Igor Laskowski, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kate McGinigle, MD       katharine_mcginigle@med.unc.edu   
Principal Investigator: Kate McGinigle, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Cynthia Shortell, MD       cynthia.shortell@dm.duke.edu   
Principal Investigator: Cynthia Shortell, MD         
Durham VAMC Recruiting
Durham, North Carolina, United States, 27705
Contact: Leila Mureebe, MD       leila.mureebe@duke.edu   
Principal Investigator: Leila Mureebe, MD         
North Carolina Heart and Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Ravish Sachar, MD       rsachar@gmail.com   
Principal Investigator: Ravish Sachar, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Justin Hurie, MD       jhurie@wakehealth.edu   
Principal Investigator: Justin Hurie, MD         
United States, Ohio
Case Western Reserve Recruiting
Cleveland, Ohio, United States, 44106
Contact: Vikram Kashyap, MD       Vikram.Kashyap@uhhospitals.org   
Principal Investigator: Vikram Kashyap, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44109
Contact: Mehdi Shishehbor, DO, MPH       shishem@ccf.org   
Principal Investigator: Mehdi Shishehbor, DO, MPH         
MetroHealth Cleveland Withdrawn
Cleveland, Ohio, United States, 44109
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jean Starr, MD       Jean.Starr@osumc.edu   
Principal Investigator: Jean Starr, MD         
Ohio Health Research Institute Active, not recruiting
Columbus, Ohio, United States, 43214
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43615
Contact: Munier Nazzal, MD       Munier.nazzal@utoledo.edu   
Principal Investigator: Munier Nazzal, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Beau Hawkins, MD       beau-hawkins@ouhsc.edu   
Principal Investigator: Beau Hawkins, MD         
Oklahoma Foundation for Cardiovascular Research Withdrawn
Oklahoma City, Oklahoma, United States, 73120
University of Oklahoma College of Medicine at Tulsa Recruiting
Tulsa, Oklahoma, United States, 74135
Contact: Kevin Taubman, MD       kevin-taubman@ouhsc.edu   
Principal Investigator: Kevin Taubman, MD         
United States, Oregon
Providence Heart and Vascular Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Ethan Korngold, MD       Ethan.korngold@providence.org   
Principal Investigator: Ethan Korngold, MD         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Erica Mitchell, MD       mitcheer@ohsu.edu   
Principal Investigator: Erica Mitchell, MD         
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Amir Azarbal, MD       Amir.azarbal@va.gov   
Principal Investigator: Amir Azarbal, MD         
Sacred Heart Hospital River Bend Withdrawn
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Faisal Aziz, MD       faziz@hmc.psu.edu   
Principal Investigator: Faisal Aziz, MD         
Thomas Jefferson University Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Eric Choi, MD       Eric.Choi@tuhs.temple.edu   
Principal Investigator: Eric Choi, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Satish Mulk, MD       SMULUK@wpahs.org   
Principal Investigator: Satish Muluk, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Rabih Chaer, MD       chaerra@upmc.edu   
Principal Investigator: Rabih Chaer, MD         
Pinnacle Health System Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: William Bachinsky, MD       wbachinsky@pinnaclehealth.org   
Principal Investigator: William Bachinsky, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Jeffrey Slaiby, MD       jslaiby@usasurg.org   
Principal Investigator: Jeffrey Slaiby, MD         
The Miriam Hospital/Brown Medical School Recruiting
Providence, Rhode Island, United States, 02906
Contact: Peter Soukas, MD       psoukas@lifespan.org   
Principal Investigator: Peter Soukas, MD         
United States, South Carolina
Roper Hospital Withdrawn
Charleston, South Carolina, United States, 29401
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Thomas Brothers, MD       brothete@musc.edu   
Principal Investigator: Thomas Brothers, MD         
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Tod Hanover, MD       thanover@ghs.org   
Principal Investigator: Tod Hanover, MD         
United States, South Dakota
North Central Heart Institute Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Michael Bacharach, MD       mbacharach@ncheart.com   
United States, Tennessee
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Chris Metzger, MD       cmetzger@mycva.com   
Principal Investigator: Chris Metzger, MD         
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Laura Findeiss, MD       lfindeiss@utmck.edu   
Principal Investigator: Laura Findeiss, MD         
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: J. Gregory Modrall, MD       greg.modrall@utsouthwestern.edu   
Principal Investigator: J. Gregory Modrall, MD         
Memorial Hermann Hospital TMC Recruiting
Houston, Texas, United States, 77030
Contact: Ali Azizzadeh, MD       Ali.Azizzadeh@uth.tmc.edu   
Principal Investigator: Ali Azizzadeh, MD         
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Neal Barshes, MD, MPH       Neal.barshes@va.gov   
Principal Investigator: Neal Barshes, MD, MPH         
Scott and White - Temple Recruiting
Temple, Texas, United States, 76508
Contact: Todd Bohannon, MD       wbohannon@swmail.sw.org   
Principal Investigator: Todd Bohannon, MD         
United States, Utah
The University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Benjamin Brooke, MD       benjamin.brooke@hsc.utah.edu   
Principal Investigator: Benjamin Brooke, MD         
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Julie Adams, MD       julie.adams@vtmednet.org   
Principal Investigator: Julie Adams, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Margaret Tracci, MD       msc7s@virginia.edu   
Principal Investigator: Margaret Tracci, MD         
Inova Heart & Vascular Recruiting
Falls Church, Virginia, United States, 22042
Contact: Dipankar Mukherjee, MD       dipankar.mukherjee@inova.org   
Principal Investigator: Dipankar Mukherjee, MD         
Sentara Vascular Specialists Recruiting
Norfolk, Virginia, United States, 23507
Contact: David Dexter, MD       ddextermd@gmail.com   
Principal Investigator: David Dexter, MD         
United States, Washington
Benaroya Research Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101
Contact: Derek Nathan, MD       Derek.nathan@virginiamason.org   
Principal Investigator: Derek Nathan, MD         
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Niten Singh, MD       Singhn2@uw.edu   
Principal Investigator: Niten Singh, MD         
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Robert Bersin, MD       Robert.Bersin@swedish.org   
Principal Investigator: Robert Bersin, MD         
Providence Sacred Heart Medical Center Active, not recruiting
Spokane, Washington, United States, 99204
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Patrick Stone, MD       pstone0627@yahoo.com   
Principal Investigator: Patrick Stone, MD         
United States, Wisconsin
Gundersen Health System Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Ezana Azene, MD       emazene@gundersenhealth.org   
Principal Investigator: Ezana Azene, MD         
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53706
Contact: John Hoch, MD       hoch@surgery.wisc.edu   
Principal Investigator: John Hoch, MD         
Meriter Wisconsin Heart Recruiting
Madison, Wisconsin, United States, 53713
Contact: Victor Weiss, MD       Vweiss@meriter.com   
Principal Investigator: Victor Weiss, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parag Patel, MD       papatel@mcw.edu   
Principal Investigator: Parag Patel, MD         
Milwaukee VAMC Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Kellie Brown, MD       krbrown@mcw.edu   
Principal Investigator: Kellie Brown, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Jerry Chen, MD       Jerry.Chen@vch.ca   
Principal Investigator: Jerry Chen, MD         
Canada, Manitoba
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Randolph Guzman, MD       rguzman@sbgh.mb.ca   
Principal Investigator: Randolph Guzman, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Science Center Recruiting
Halifax, Nova Scotia, Canada, B3H3A7
Contact: Christine Herman, MD       cherman@dal.ca   
Principal Investigator: Christine Herman, MD         
Canada, Ontario
University of Western Ontario Recruiting
London, Ontario, Canada, N6A5W9
Contact: Audra Duncan       Audra.Duncan@lhsc.on.ca   
Principal Investigator: Audra Duncan, MD         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: Sudhir Nagpal, MD       snagpal@toh.ca   
Principal Investigator: Sudhir Nagpal, MD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Thomas Lindsay, MDCM, MSc       Thomas.Lindsay@uhn.ca   
Principal Investigator: Thomas Lindsay, MDCM, MSc         
Canada, Quebec
McGill Recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Kent Mackenzie, MD       kent.mackenzie@muhc.mcgill.ca   
Principal Investigator: Kent Mackenzie, MD         
Jewish General Hostpital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Daniel Obrand, MD       dobrand@jgh.mcgill.ca   
Principal Investigator: Daniel Obrand, MD         
Chu de Quebec Recruiting
Quebec City, Quebec, Canada, G1L 3L5
Contact: Yvan Douville, MD       yvan.douville@chg.ulaval.ca   
Principal Investigator: Yvan Douville, MD         
Canada, Saskatchewan
Regina Qu'Appelle Recruiting
Regina, Saskatchewan, Canada, S4P 0W5
Contact: David Kopriva, MDCM       dkopriva@sasktel.net   
Principal Investigator: David Kopriva, MDCM         
St. Paul's Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7M0Z9
Contact: Bruce DuVal, MD       bruce.duval@usask.ca   
Principal Investigator: Bruce DuVal, MD         
Sponsors and Collaborators
New England Research Institutes
Brigham and Women's Hospital
Massachusetts General Hospital
Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
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: Flora S Siami, MPH New England Research Institutes, Inc.
Principal Investigator: Susan Assmann, PhD New England Research Institutes, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02060630     History of Changes
Other Study ID Numbers: BEST-CLI Trial
1U01HL107407 ( U.S. NIH Grant/Contract )
Study First Received: February 6, 2014
Last Updated: June 20, 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by New England Research Institutes:
Surgical revascularization
Endovascular revascularization
Amputation
Peripheral artery disease
Critical limb ischemia
claudication
leg pain
leg ulcer
gangrene

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2017