Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Status: Recruiting
Location: See all (160) locations...
Intervention Type: Device, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 100
Healthy Volunteers: No
View:

• Patients ≥35 years old.

• Carotid stenosis defined as:

• Stenosis ≥70% by catheter angiography (NASCET Criteria); OR

• by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following:

• an end diastolic velocity ≥100 cm/s, or

• internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or

• CTA with ≥ 70% stenosis, or

• MRA with ≥ 70% stenosis.

• No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).18

• Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent.

• Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.

• Patients must agree to comply with all protocol-specified follow-up appointments.

• Patients must sign a consent form that has been approved by the local governing Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.

• Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer).

• Carotid stenosis must be treatable with CEA, CAS, or either procedure.

Locations
United States
Alabama
Brookwood Medical Center
Recruiting
Birmingham
The University of Alabama at Birmingham
Recruiting
Birmingham
Huntsville Hospital/ Heart Center Research Alabama
Recruiting
Huntsville
Arkansas
Central Arkansas Veteran's Healthcare System
Recruiting
Little Rock
Arizona
Abrazo Arizona Heart Hospital
Active, not recruiting
Phoenix
Banner University
Recruiting
Phoenix
Mayo Clinic Arizona
Recruiting
Phoenix
St. Joseph's Hospital and Medical Center/ Barrow Neurological Institute
Recruiting
Phoenix
HonorHealth Scottsdale Osborn Medical Center
Recruiting
Scottsdale
University of Arizona
Recruiting
Tucson
California
Mission Cardiovascular Research
Recruiting
Fremont
UC San Diego Health
Recruiting
La Jolla
Cedars-Sinai Medical Center
Recruiting
Los Angeles
Kaiser Permanente Los Angeles
Recruiting
Los Angeles
Keck Medical Center of University of Southern California
Recruiting
Los Angeles
University of California Los Angeles (UCLA)
Recruiting
Los Angeles
VA Palo Alto Health Care System
Recruiting
Palo Alto
Kaiser Permanente
Recruiting
San Diego
Kaiser Permanente Northern California
Recruiting
San Francisco
San Francisco VA Medical Center
Recruiting
San Francisco
University of California San Francisco
Active, not recruiting
San Francisco
Stanford University Medical Center
Recruiting
Stanford
St. Joseph's Medical Center
Recruiting
Stockton
Providence Little Company of Mary Medical Center
Recruiting
Torrance
Colorado
St. Mary's Medical Center
Active, not recruiting
Grand Junction
Medical Center of the Rockies
Recruiting
Loveland
Connecticut
Hartford Hospital
Recruiting
Hartford
Yale New Haven Hospital
Recruiting
New Haven
Washington, D.c.
Washington Hospital Center/Medstar
Active, not recruiting
Washington
Florida
Morton Plant Hospital
Recruiting
Clearwater
University of Florida Health at Shands
Recruiting
Gainesville
First Coast Cardiovascular Institute
Recruiting
Jacksonville
Lyerly Neurosurgery
Recruiting
Jacksonville
Mayo Clinic
Recruiting
Jacksonville
UF Jacksonville
Recruiting
Jacksonville
Miami Cardiac and Vascular Institute at Baptist Hospital of Miami
Recruiting
Miami
University of Miami Hospital
Recruiting
Miami
Mount Sinai Medical Center of Florida
Active, not recruiting
Miami Beach
Cardiovascular Institute of Northwest Florida
Active, not recruiting
Panama City
Tallahassee Neurological Clinic
Recruiting
Tallahassee
Tampa General Hospital /University of South Florida
Active, not recruiting
Tampa
Georgia
Atlanta VA Medical Center
Recruiting
Atlanta
Emory University
Recruiting
Atlanta
Iowa
University of Iowa
Recruiting
Iowa City
Illinois
Southern Illinois Healthcare
Recruiting
Carbondale
The University of Chicago Medical Center
Recruiting
Chicago
Northwestern University
Recruiting
Evanston
Loyola University Medical Center
Suspended
Maywood
Mercy Health Riverside
Recruiting
Rockford
Prairie Heart/St. John's Hospital
Recruiting
Springfield
Indiana
Franciscan St. Francis Health
Recruiting
Indianapolis
The Heart Group, PC
Active, not recruiting
Newburgh
Kansas
University of Kansas Medical Center
Recruiting
Kansas City
Kentucky
Baptist Health Lexington
Recruiting
Lexington
University of Kentucky Hospital
Recruiting
Lexington
University of Louisville
Active, not recruiting
Louisville
Louisiana
Ochsner Health System
Recruiting
New Orleans
Tulane University
Active, not recruiting
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center (BIDMC)
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
St. Elizabeth's Medical Center
Recruiting
Boston
University of Massachusetts Memorial Hospital
Recruiting
Worcester
Maryland
John Hopkins Medical Institution
Active, not recruiting
Baltimore
University of Maryland VA
Recruiting
Baltimore
White Oak Medical Center
Recruiting
Takoma Park
Maine
Maine Medical Center
Recruiting
Portland
Michigan
University of Michigan Hospital and Health Systems
Recruiting
Ann Arbor
VA Ann Arbor Healthcare System
Recruiting
Ann Arbor
Henry Ford Health System
Recruiting
Detroit
Michigan Vascular Center/McLaren- Flint
Recruiting
Flint
Sparrow Clinical Research Institute
Recruiting
Lansing
Cardiac and Vascular Research Center of Northern Michigan/McLaren Northern Michigan
Active, not recruiting
Petoskey
William Beaumont Hospital
Recruiting
Royal Oak
Trinity Health/ Michigan Heart
Recruiting
Ypsilanti
Minnesota
Minneapolis Clinic of Neurology, Ltd./ North Memorial Medical Center
Recruiting
Golden Valley
Hennepin County Medical Center
Active, not recruiting
Minneapolis
University of Minnesota
Recruiting
Minneapolis
Mayo Clinic Rochester
Recruiting
Rochester
St. Cloud Hospital
Active, not recruiting
Saint Cloud
Missouri
John Cochran St. Louis Medical Center
Recruiting
Saint Louis
Mercy Hospital
Recruiting
Saint Louis
Cox Medical Center
Recruiting
Springfield
Mercy Medical Research Institute
Active, not recruiting
Springfield
North Carolina
Duke University Medical Center
Recruiting
Durham
North Carolina Heart & Vascular Research
Recruiting
Raleigh
Coastal Carolina Surgical Associates PA
Recruiting
Wilmington
Novant Health/Forsyth Medical Center
Recruiting
Winston-salem
Wake Forest University Health Sciences
Recruiting
Winston-salem
New Hampshire
Dartmouth-Hitchcock Medical Center
Active, not recruiting
Lebanon
New Jersey
Cooper University
Recruiting
Camden
Hackensack University Medical Center
Recruiting
Hackensack
New York
SUNY Buffalo
Recruiting
Buffalo
The Feinstein Institute of Medical Research
Recruiting
Manhasset
Columbia University Medical Center
Recruiting
New York
Mount Sinai Hospital New York
Recruiting
New York
Weill Cornell Medical College
Recruiting
New York
University of Rochester
Recruiting
Rochester
St. Francis Hospital
Recruiting
Roslyn
Crouse Hospital
Recruiting
Syracuse
Ohio
University of Cincinnati Medical Center
Active, not recruiting
Cincinnati
Louis Stokes Cleveland VA Medical Center
Recruiting
Cleveland
University Hospitals Cleveland Medical Center
Recruiting
Cleveland
Ohio State Medical Center
Recruiting
Columbia
OhioHealth Research Institute
Recruiting
Columbus
Jobst Vascular Institute/Toledo Hospital
Active, not recruiting
Toledo
Mercy Health St.Vincent Medical Center
Recruiting
Toledo
Oklahoma
St. John Clinical Research Institute
Active, not recruiting
Tulsa
Oregon
Oregon Health & Science University
Recruiting
Portland
Providence Brain and Spine Institute
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital - Network Office of Research
Recruiting
Allentown
UPMC Altoona
Recruiting
Altoona
Doylestown Hospital
Recruiting
Doylestown
UPMC Hamot
Recruiting
Erie
PennState Health Milton S. Hershey Medical Center
Recruiting
Hershey
Hospital of the University of Pennsylvania
Recruiting
Philadelphia
Thomas Jefferson University Hospital
Recruiting
Philadelphia
UPMC Presbyterian University Hospital
Recruiting
Pittsburgh
VA Pittsburgh Healthcare
Recruiting
Pittsburgh
Pinnacle Health Cardiovascular Institute
Recruiting
Wormleysburg
Lankenau Medical Center
Recruiting
Wynnewood
Berks Cardiologists / St. Joseph's Medical Center
Recruiting
Wyomissing
Rhode Island
The Miriam Hospital
Recruiting
Providence
South Carolina
Medical University of South Carolina
Recruiting
Charleston
South Dakota
North Central Heart Institute
Recruiting
Sioux Falls
Tennessee
CVA Heart Institute
Recruiting
Kingsport
Tennova Healthcare/ Turkey Creek Medical Center
Recruiting
Knoxville
Baptist Memorial Hospital
Recruiting
Memphis
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Cardiothoracic and Vascular Surgeons
Active, not recruiting
Austin
Seton Medical Center Austin
Recruiting
Austin
University of Texas Southwestern Medical Center
Recruiting
Dallas
Valley Baptist Medical Center
Recruiting
Harlingen
Houston Methodist Hospital
Recruiting
Houston
Memorial Hermann Texas Medical Center
Active, not recruiting
Houston
Utah
Intermountain Medical Center
Recruiting
Murray
George E. Wahlen Department of Veterans Affairs Medical Center
Recruiting
Salt Lake City
University of Utah Hospitals and Clinics
Recruiting
Salt Lake City
Virginia
University of Virginia Health System
Recruiting
Charlottesville
Inova Fairfax Health Care
Recruiting
Falls Church
Winchester Medical Center
Active, not recruiting
Winchester
Washington
Overlake Hospital Medical Center
Recruiting
Bellevue
Swedish Medical Center
Active, not recruiting
Seattle
University of Washington Medicine-Harborview Medical Center
Recruiting
Seattle
VA Puget Sound Health Care System
Recruiting
Seattle
Providence Sacred Heart Medical Center
Active, not recruiting
Spokane
Wisconsin
Gundersen Clinic, Ltd
Recruiting
La Crosse
University of Wisconsin
Recruiting
Madison
West Virginia
West Virginia University
Recruiting
Morgantown
Other Locations
Australia
Fiona Stanley Hospital
Recruiting
Perth
Canada
Nova Scotia Health Authority
Recruiting
Halifax
CHU de Québec/ Hôpital de l'Enfant-Jésus
Recruiting
Québec City
St. Michael's Hospital
Recruiting
Toronto
Vancouver General Hospital
Recruiting
Vancouver
St. Boniface Hospital
Recruiting
Winnipeg
Israel
Soroka University Medical Center
Recruiting
Be'er Sheva
Soroka University Vascular Surgery
Recruiting
Be'er Sheva
Rambam Healthcare
Recruiting
Haifa
Shaare-Zedek Medical Center
Recruiting
Jerusalem
Rabin Medical Center
Recruiting
Petach Tikva
Spain
Hospital Clinic Barcelona
Recruiting
Barcelona
Contact Information
Primary
CREST-2 Administrative Center
844-956-1826
Time Frame
Start Date: December 2014
Estimated Completion Date: February 2026
Participants
Target number of participants: 2480
Treatments
Active Comparator: Carotid Endarterectomy (CEA)
Carotid Endarterectomy
Active Comparator: Carotid Stenting (CAS)
Carotid Stenting
Experimental: Intensive Medical Management - no CEA
Intensive Medical Management alone - no CEA
Experimental: Intensive Medical Management - no CAS
Intensive Medical Management alone - no CAS
Authors
Pete Monteleone, Lee Burke, Simon Tran, Parth Shaw, Steven Guidera, Venkata Emani, Osvaldo Gigliotti, Amir Haghighat, Raghu Ramaswamy, Olamide Alabi, Scott Westfall, Tapan Thacker, Scott Simon, David Weatherford, Andrew Ducruet, Vikram Kashyap, Adam Arthur, Shipra Arya, Scott Silverman, Lawrence Garcia, Jason Tarpley, Amelia Adcock, Warren J Gasper, Albert Hakaim, Carlos Mena-Hurtado, Gilles Pinault, Anna Wanahita, Camilo Gomez, Nicholas Osborne, John Castaldo, Hollace Chastain, Guy N. Piegari, Venkatesh Ramaiah, Theodore Lowenkopf, Bart Demaerschalk, Andrew Ringer, Avery Evans, Jana Wold, Oliver Aalami, Girma Tefera, George Howard, Michael Froehler, Wesley Moore, Tudor Jovin, Edith Tzeng, Mitchell Weaver, David Chiu, Mandip Dhamoon, Akhilesh Jain, Jennifer Majersik, Pierre Leimgruber, Mazin Foteh, Emad Zakhary, Yazan Duwayri, Thomas G. Brott, Jon S. Matsumura, Wei Liu, Steven Katz, Fareed K Suri, Paul Huang, Brajesh K Lal, Wayne Clark, Barry Katzen, Robert K Rogers, Fayaz Shawl, Massimo Napolitano, James Brorson, Gary Roubin, William Gray, Jean Starr, Nicole Gonzales, Edward Plecha, Mitchell Silver, Brett Cucchiara, Stanley Tuhrim, Cynthia Shortell, Yevgeniy Isayev, Todd Russell, Mark Eskandari, James F. Meschia, Philip Huber, Jonathan Berry, David Tirschwell, Jamal Zarghami, Parth Shah, Irfan Altafullah, Cheryl Bushnell, Edward Woo, Matthew Flaherty, Robert Molnar, Ajit Puri, Seemant Chaturvedi, Patrick Ireland, Daniel Soffer, Joel Cohn, Jeffrey Goldstein, Fred Weaver, Ashit Jain, Robert Beasley, Dipankar Mukherjee, Richard Petrella, William Bachinsky, Richard Powell, Navdeep Sangha, Jason Ricci, Douglas Franz, William Berg, Richard Kovach, Mai Nguyen-Huynh, Shahab Toursavadkohi, Gale Tang, Dan-Victor Giurgiutiu, Adnan Siddiqui, Warren Strickland, Vaqar Ali, Edward Miner, Mark Harrigan, Marc Schermerhorn, Herbert Aronow, Michael Alexander, Gary Steinberg, Mustapha Ezzeddine, Osama Zaidat, Wei Zhou, Mansoor Qureshi, Donald Heck, Dana Leifer, Giuseppe Lanzino, Matthew Starr, Clark Davis, Matthew Lawson, Maxim Mokin, David Kandzari, Lawrence Wechsler, Logan McDaneld, Gary Ansel, Ravi Veeraswamy, George Petrossian, Andrew W. Grande, Pascal Jabbour, Mouhammed Kabbani, Dileep Yavagal, Michael Jones, Peter Henke, Mohammed Moursi, Ricardo Hanel, Chad Stoltz, Robert Ecker, Ravish Sachar, Sean Lyden, Joseph Rapp, Mahmoud Malas, Malcolm Foster, James Cavender, Alexander Shepard, Bogachan Sahin, Cynthia Kenmuir, Mounir Haurani, Raed Al-Dallow, Richard McCann, Gregory Modrall, Kathleen Gibson, George Greenberg, Ashu Jadhav, Toby Richards, John Mullins, Albert Sam, Robert Hye, Sarah Johnson, Michael Mullen, Eric Lopez del Valle, O. William Brown, Karl Illig, Walter Montanera, Fenwick Nichols, Sarasijhaa Desikan, Creed Pettigrew, Vibhav Bansal, Roni Eichel, Randolph Guzman, Philip Teal, Michel Makaroun, Chris Metzger, Christine Holmstedt, Wondwossen Tekle, Anat Horev, Mel Sharafuddin, Angel Chamorro, Kamal Gupta, Wade Smith, Bob Bersin, Robert Chang, Fayza Shawl, Scott Duff, Ariane Mackey, Shlomi Peretz, Joseph Zabramski, Randolph Marshall, Ameer Hassan, Henry Woo, Randall Edgell, Christine Herman, Michael Bacharach, Anna Khanna, David Tanne, Tom Marotta, Charles Sternbergh III
Sponsors
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Thomas G. Brott, M.D.

This content was sourced from clinicaltrials.gov

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