Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

Status: Completed
Location: See all (161) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Alabama
The University of Alabama at Birmingham
Birmingham
Arkansas
University of Arkansas for Medical Services
Little Rock
Arizona
Arizona Heart Hospital
Phoenix
Carondelet Heart & Vascular Institute
Tucson
University of Arizona - Banner University Medical Center
Tucson
California
University of California - Irvine
Irvine
San Diego VAMC
La Jolla
UC San Diego Sulpizio Cardiovascular Center
La Jolla
Loma Linda University Medical Center
Loma Linda
Loma Linda VA Medical Center
Loma Linda
VA Long Beach Healthcare System
Long Beach
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Keck Medical Center of USC
Los Angeles
UCLA-Gonda Vascular Surgery
Los Angeles
VA Greater Los Angeles
Los Angeles
VA Palo Alto Health Care
Palo Alto
Sacramento VA Medical Center
Sacramento
University of California Davis Medical Center
Sacramento
Kaiser Permanente (San Diego)
San Diego
Kaiser Permanente Northern California
San Francisco
San Francisco Veterans Affairs Medical Center
San Francisco
University of California-San Francisco Medical Center
San Francisco
Stanford Hospital
Stanford
Harbor - UCLA Medical Center
Torrance
Colorado
University of Colorado Hospital
Aurora
Denver Health
Denver
Rocky Mountain Regional VA
Denver
Vascular Institute of the Rockies
Denver
Connecticut
St. Francis Hospital and Medical Center
Hartford
Yale-New Haven Hospital
New Haven
West Haven VAMC
West Haven
Washington, D.c.
GW Medical Faculty Associates, Inc.
Washington
Medstar Washington Hospital Center
Washington
Florida
University of Florida (Gainesville)
Gainesville
Baptist Hospital of Miami
Miami
Mount Sinai Miami
Miami Springs
Florida Hospital Ocala
Ocala
Tampa General Hospital
Tampa
Tampa VAMC
Tampa
Georgia
Emory University
Atlanta
Atlanta VA Medical Center
Decatur
Hawaii
Kaiser Foundation Hospital
Honolulu
Iowa
Mercy Hospital Medical Center
West Des Moines
Illinois
Central DuPage Hospital (Cadence)
Chicago
Rush University Medical Center
Chicago
University of Chicago Medicine
Chicago
Decatur Memorial Hospital
Decatur
Loyola University Medical Center
Maywood
Southern Illinois University School of Medicine
Springfield
Northwestern Memorial Hospital
Winfield
Indiana
Indiana University Medical School
Indianapolis
Louisiana
Ochsner Medical Center
New Orleans
University Health System: LSU Health Sciences
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Boston Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
VA Boston Healthcare System
Boston
Steward St. Elizabeth's Medical Center
Brighton
South Shore Hospital
Weymouth
University of Massachusetts Medical School
Worcester
Maryland
Johns Hopkins Hospital
Baltimore
Loyola University Medical Center
Baltimore
MedStar Union Memorial Hospital
Baltimore
University of Maryland Medical System
Baltimore
Maine
Maine Medical Center
Portland
Michigan
Michigan Heart/St. Joseph Mercy Ann Arbor Hospital
Ann Arbor
University of Michigan Health System
Ann Arbor
VA Ann Arbor Healthcare System
Ann Arbor
Henry Ford Health System
Detroit
Michigan Vascular Center
Flint
Spectrum Health
Grand Rapids
William Beaumont Hospital
Royal Oak
Minnesota
Minneapolis Heart Hospital/Abbott Northwestern Hosp.
Minneapolis
Minneapolis VAMC
Minneapolis
Mayo Clinic
Rochester
Missouri
University of Missouri
Columbia
Midwest Aortic Vascular Institute
Kansas City
St. Louis VA Medical Center
Saint Louis
North Carolina
University of North Carolina
Chapel Hill
Duke University
Durham
Durham VAMC
Durham
North Carolina Heart and Vascular Research
Raleigh
Wake Forest Baptist Medical Center
Winston-salem
Nebraska
University of Nebraska Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Hanover
New Jersey
Deborah Heart and Lung Center
Browns Mills
Englewood Hospital and Medical Center
Englewood
Rutgers New Jersey Medical School
Newark
Holy Name Medical Center
Teaneck
New Mexico
New Mexico Heart Institute
Albuquerque
New Mexico VA Medical Center
Albuquerque
New York
Albany Medical Center
Albany
Montefiore Medical Center
Bronx
VA Western NY Healthcare System
Buffalo
Columbia University Medical Center
New York
Mount Sinai Medical Center
New York
Vascular Health Partners
Queensbury
University of Rochester Medical Center
Rochester
Staten Island University Hospital
Staten Island
Stony Brook Medicine
Stony Brook
SUNY Upstate Medical University
Syracuse
Westchester Medical Center
Valhalla
Ohio
Cleveland Clinic Foundation
Cleveland
University Hospitals of Cleveland/Case Western Reserve University
Cleveland
Ohio Health Research Institute
Columbus
The Ohio State University
Columbus
University of Toledo Medical Center
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
University of Oklahoma College of Medicine at Tulsa
Tulsa
Oregon
Oregon Health and Science University
Portland
Portland VA Medical Center
Portland
Providence Heart and Vascular Institute
Portland
Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey
Temple University
Philadelphia
Allegheny General Hospital
Pittsburgh
University of Pittsburgh Medical Center
Pittsburgh
Pinnacle Health System
Wormleysburg
Rhode Island
Rhode Island Hospital
Providence
The Miriam Hospital/Brown Medical School
Providence
South Carolina
Medical University of South Carolina
Charleston
Prisma Health-Upstate (Formerly Greenville Memorial Hospital)
Greenville
South Dakota
North Central Heart Institute
Sioux Falls
Tennessee
Wellmont Holston Valley Medical Center
Kingsport
University of Tennessee Medical Center
Knoxville
Texas
Dallas VA Medical Center
Dallas
Memorial Hermann Hospital TMC
Houston
Michael E. DeBakey VA Medical Center
Houston
Scott and White - Temple
Temple
Utah
The University of Utah
Salt Lake City
Virginia
University of Virginia
Charlottesville
Inova Fairfax Hospital
Falls Church
Sentara Vascular Specialists
Norfolk
Vermont
University of Vermont Medical Center
Burlington
Washington
Benaroya Research Institute at Virginia Mason
Seattle
Harborview Medical Center
Seattle
Swedish Medical Center
Seattle
Providence Sacred Heart Medical Center
Spokane
Wisconsin
Gundersen Health System
La Crosse
Meriter Wisconsin Heart
Madison
University of Wisconsin-Madison
Madison
Medical College of Wisconsin
Milwaukee
Milwaukee VAMC
Milwaukee
West Virginia
CAMC Clinical Trials Center
Charleston
Other Locations
Canada
Queen Elizabeth II Health Science Center
Halifax
University of Western Ontario
London
Jewish General Hostpital
Montreal
McGill
Montreal
The Ottawa Hospital
Ottawa
Chu de Quebec
Quebec City
Regina Qu'Appelle
Regina
St. Paul's Hospital
Saskatoon
Sunnybrook Health Sciences Centre
Toronto
Toronto General Hospital
Toronto
Vancouver General Hospital
Vancouver
St. Boniface General Hospital
Winnipeg
Finland
Helsinki University Hospital
Helsinki
Italy
San Giovanni di Dio Hospital
Florence
New Zealand
Auckland City Hospital
Grafton
Waikato Hospital
Hamilton
Wellington Hospital
Newtown
Time Frame
Start Date: August 2014
Completion Date: March 1, 2022
Participants
Target number of participants: 1843
Treatments
Other: Available vein, open surg. revasc.
Subjects with an available SSGSV cohort randomized to open surgical revascularization
Other: Available vein, endovasc. revasc.
Subjects with an available SSGSV cohort randomized to endovascular revascularization
Other: Alternative conduit, open surg. revasc.
Subjects with an alternative conduit cohort randomized to open surgical revascularization
Other: Alternative conduit, endovasc. revasc.
Subjects with an alternative conduit cohort randomized to endovascular revascularization
Authors
Abulhameed Aziz, Gregory Hayes, Nassim Hedayati, Luis Figueroa, J. Gregory Modrall, Kate McGinigle, Sikalas, Ying Wei Lum, Bruce DuVal, G. Matthew Longo, Stephen Henao, Craig Seidman, Peter Nelson, J. Stephen Jenkins, Raghuveer Vallabhaneni, Robert Feldman, Marc Passman, Frank Pomposelli, Allen Hamdan, Neal Barshes, Marcus Semel, Kristofer Charlton-Ouw, Nii-Kabu Kabutey, Venita Chandra, Luke Brewster, Bernadette Aulivola, Vikram Kashyap, Elizabeth Blazick, Amir Azarbal, John Rundback, Timothy Nypaver, Warren Gasper, Andrey Espinoza, Jeffrey Trachtenberg, Margaret Tracci, Carlos Mena-Hurtado, Rabih Chaer, Scott Fecteau, Alik Farber, Kim Hodgson, Thomas Bernik, Robert Crawford, Nicholas Osborne, Satish Muluk, Ross Milner, Stephen Hass, Venkatesh Ramaiah, Ian Gordon, Oliver Aalami, Leila Mureebe, David McAllister, Jade Hiramoto, Ethan Korngold, Manish Mehta, Martin Back, Todd Bohannon, Kenneth Rosenfield, Daniel Ihnat, Catherine Chang, Robert Safian, Christopher Owens, Justin Simmons, Robert Hacker, Peter Lawrence, Areck Ucuzian, Mark Iafrati, Steven Pfau, Andre Artis, Andres Schanzer, Khusrow Niazi, Aamir Shah, Kevin Taubman, Yazan Duwayri, John Blebea, Mehdi Shishehbor, Igor Laskowski, William Pevec, Manju Kalra, John Hoch, Victor Weiss, Rodney White, Murray Shames, Enjae Jung, Ahmed Kayssi, Linda Chun, Thomas Huber, Faisal Aziz, Brian Halloran, Kellie Brown, Kaushal Patel, Eric Choi, Jean Starr, Evan Lipsitz, Michael Belkin, Ezana Azene, Julie Adams, Cynthia Shortell, Erika Ketteler, Beau Hawkins, John Eidt, James Benenati, Mark Eskandari, Hasan Dosluoglu, Scott Kujath, Robert Molnar, Jeffrey Kalish, Joseph Griffin, Robert Beasley, Dipankar Mukherjee, Danielle Bajakian, Jeffrey Slaiby, Vincent Rowe, Julia Wilkinson, Matthew Menard, Todd Vogel, Glenn LaMuraglia, Amy Reed, William Bachinsky, Palma Shaw, Munier Nazzal, Niten Singh, Ahmed Abou-Zamzam, Ehrin Armstrong, Peter Schneider, Richard Kovach, Matthew Smeds, William Jordan, Cheong J Lee, Tod Hanover, Patrick Stone, Scott Kinlay, Peter Soukas, Wei Zhou, Scott Berman, Ageliki Vouyouka, Chiranjiv Virk, Robert Bersin, Audra Duncan, Gary Ansel, Christian Bianchi, Ulku Cenk Turba, Hugh Gelabert, Peter Henke, Jason Alexander, Jonathan Schor, Ravish Sachar, Sean Lyden, Nelson Bernardo, Derek Nathan, Parag Patel, Sapan Desai, Michael Stoner, Joseph Davis, Robyn Macsata, Timothy Wu, John You, Janaka K Wickremesekera, Matthew Mell, Brandon T Garland, Michael Verta, Robert Hye, Andrew Hill, James Brooks, Taye Hamza, Mark Cziraky, Justin Hurie, Erica Mitchell, Jerry Chen, Richard Neville, Mohamed Zayed, Randolph Guzman, R. Clement Darling, Thodur Vasudevan, Thomas Brothers, David Kopriva, Nicolas Shammas, John Lane, Chris Metzger, Tze-Woei Tan, Stefano Michelagnoli, Paul Armstrong, Robert Chang, Wayne Zhang, Mohammed Zayed, Gregory Von Mering, Raghu Vallabhaneni, Kevin Rogers, Yvan Douville, Eyal Ben-Arie, Sudhir Nagpal, Flora S Siami, Daniel Obrand, Susan Assmann, Thomas Lindsay, Benjamin Brooke, Kristina Giles, Maarit Venermo, Raghu Motaganahalli, Kent Mackenzie, Christine Herman, Laura Findeiss, Ali Azizzadeh, David Dexter
Sponsors
Collaborators: Eastern Vascular Society, Society for Vascular Surgery, Gore, Cardiovascular Systems Inc, Southern Vascular Society, Vascular Interventional Advances, Canadian Society for Vascular Surgery, Society for Interventional Radiology, Society for Clinical Vascular Surgery, Society for Vascular Medicine, Boston Scientific Corporation, Abbott, Boston Medical Center, Midwest Vascular Society, Massachusetts General Hospital, Western Vascular Society, National Heart, Lung, and Blood Institute (NHLBI), New England Society for Vascular Surgery, Brigham and Women's Hospital, Cordis Corporation, Vascular and Endovascular Surgery Society, Bard Ltd
Leads: HealthCore-NERI

This content was sourced from clinicaltrials.gov

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