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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02089217
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Thomas G. Brott, M.D., Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Procedure: Carotid endarterectomy (CEA) Device: Carotid Stenting (CAS) Other: Intensive Medical Management - no CEA Other: Intensive Medical Management - no CAS Not Applicable

Detailed Description:

Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries.

The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not.

The trial will be conducted in the United States and Canada by physicians carefully selected on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for 4 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
Masking: Single (Investigator)
Masking Description: CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
Primary Purpose: Prevention
Official Title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Carotid Endarterectomy (CEA)
Carotid Endarterectomy
Procedure: Carotid endarterectomy (CEA)
Carotid endarterectomy

Active Comparator: Carotid Stenting (CAS)
Carotid Stenting
Device: Carotid Stenting (CAS)
Carotid stenting

Experimental: Intensive Medical Management - no CEA
Intensive Medical Management alone - no CEA
Other: Intensive Medical Management - no CEA
Intensive Medical Management alone - no CEA

Experimental: Intensive Medical Management - no CAS
Intensive Medical Management alone - no CAS
Other: Intensive Medical Management - no CAS
Intensive Medical Management alone - no CAS




Primary Outcome Measures :
  1. Stroke and death [ Time Frame: 4 years ]
    The primary outcome is the composite of stroke plus death within 44 days after randomization and ipsilateral stroke thereafter up to 4 years.


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: 4 years ]
    The assess if MEDICAL management differs from CAS, and differs from CEA, to maintain the level of cognitive function at the 4-year assessment.

  2. Major Stroke [ Time Frame: 4 years ]
    if there are treatment differences in the incidence of major stroke at 4-years among all arms of the study

  3. Effect modification [ Time Frame: 4 years ]
    Potential effect modification of the CAS or CEA versus MEDICAL differences, based on patient age, sex, severity of carotid stenosis, restenosis, risk factor level, and duration of asymptomatic period.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria

  1. Patients ≥35 years old.
  2. 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:

      1. an end diastolic velocity ≥100 cm/s, or
      2. internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
      3. CTA with ≥ 70% stenosis, or
      4. MRA with ≥ 70% stenosis.
  3. 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
  4. Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent.
  5. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
  6. Patients must agree to comply with all protocol-specified follow-up appointments.
  7. 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.
  8. 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).
  9. Carotid stenosis must be treatable with CEA, CAS, or either procedure.

General Exclusion Criteria

  1. Intolerance or allergic reaction to a study medication without a suitable management alternative.
  2. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy.
  3. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes.
  4. Severe dementia.
  5. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation.
  6. Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol.
  7. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
  8. Patient objects to future blood transfusions.
  9. Platelet count <100,000/microliter or history of heparin-induced thrombocytopenia.
  10. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents.
  11. Chronic atrial fibrillation.
  12. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation.
  13. Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism.
  14. Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
  15. Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6 months.
  16. Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted value.
  17. Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for >5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment.
  18. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month.
  19. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min.
  20. Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
  21. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney).
  22. Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2.
  23. Inability to understand and cooperate with study procedures or provide informed consent.
  24. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy).
  25. Previous ipsilateral CEA or CAS.
  26. Ipsilateral internal or common carotid artery occlusion.
  27. Intra-carotid floating thrombus.
  28. Ipsilateral intracranial aneurysm > 5 mm.
  29. Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period.
  30. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized.

Specific carotid endarterectomy exclusion criteria

Patients who are being considered for revascularization by CEA must not have any of the following criteria:

  1. Serious adverse reaction to anesthesia not able to be overcome by pre-medication.
  2. Distal/intracranial stenosis greater than index lesion.
  3. Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility - inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel.

Specific Carotid Artery Stenting Exclusion Criteria

Patients who are being considered for revascularization by CAS must not have any of the following criteria:

  1. Allergy to intravascular contrast dye not amenable to pre-medication.
  2. Type III, aortic arch anatomy.
  3. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement.
  4. Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis.
  5. Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than index lesion.

    Excessive circumferential calcification of the stenotic lesion defined as >3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).)

  6. Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used.
  7. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD).
  8. Non-contiguous lesions and long lesions (>3 cm).
  9. Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath placement.
  10. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. "String sign" of the ipsilateral common or internal carotid artery.
  11. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089217


Contacts
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Contact: CREST-2 Administrative Center 844-956-1826

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Locations
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United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Rhonda Whidden    205-934-3131    rwhidden@uabmc.edu   
Principal Investigator: Mark Harrigan, MD         
Brookwood Medical Center Recruiting
Birmingham, Alabama, United States, 35243
Contact: Suzanne Frew, RN    205-795-5192    sfrew@cvapc.com   
Principal Investigator: Gary Roubin, MD         
Huntsville Hospital/ Heart Center Research Alabama Recruiting
Huntsville, Alabama, United States, 35801
Contact: Weston Smith    256-698-0405    wsmith@hsvheartmds.com   
Principal Investigator: Warren Strickland, MD         
United States, Arizona
St. Joseph's Hospital and Medical Center/ Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Norissa Honea    602-406-6267    Norissa.Honea@DignityHealth.org   
Principal Investigator: Joseph Zabramski, MD         
Abrazo Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Thomas Osgood    602-604-5021    taosgood@abrazohealth.com   
Principal Investigator: Venkatesh Ramaiah, MD         
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Erica Boyd, RN    480-342-1316    boyd.erica@mayo.edu   
Principal Investigator: Bart Demaerschalk, MD         
United States, Arkansas
Central Arkansas Veteran's Healthcare System Recruiting
Little Rock, Arkansas, United States, 72143
Contact: Sandi Brock, RN    501-257-6906    sjbrock@uams.edu   
Principal Investigator: Mohammed Moursi, MD         
United States, California
Mission Cardiovascular Research Recruiting
Fremont, California, United States, 94538
Contact: Edith Munoz    510-796-0222 ext Option 2    edith2333@cccma.org   
Principal Investigator: Ashit Jain, MD         
Kaiser Permanente Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Catherine Liu    323-783-7404    Catherine.L.Lui@kp.org   
Principal Investigator: Navdeep Sangha, MD         
Keck Medical Center of University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Sylvia Ramos    323-442-5763    SylviaL.Ramos@med.usc.edu   
Principal Investigator: Fred Weaver, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Vicki Manoukian    310-423-5067    vicki.manoukian@cshs.org   
Principal Investigator: Michael Alexander, MD         
University of California Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Kathy Walden-Land    310-206-1115    kgwalden@mednet.ucla.edu   
Principal Investigator: Wesley Moore, MD         
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Atul Nagare, MD    650-849-0357    ATUL.NAGARE@va.gov   
Principal Investigator: Oliver Aalami, MD         
Kaiser Permanente Recruiting
San Diego, California, United States, 92116
Contact: Michael Fechter    858-266-6604    michael.d.fechter@kp.org   
Principal Investigator: Edward Plecha, MD         
Kaiser Permanente Division of Research Recruiting
San Francisco, California, United States, 94115
Contact: Cristina Casias, RN    415-833-3480    cristina.casias@kp.org   
Principal Investigator: Mai Nguyen-Huynh, MD         
Principal Investigator: Robert Chang, MD         
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Sandra Perez    415-221-4810 ext 22697    sandra.perez@va.gov   
Principal Investigator: Joseph Rapp, MD         
University of California San Francisco Active, not recruiting
San Francisco, California, United States, 94143
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Maria Coburn    650-736-9551    mcoburn@stanford.edu   
Principal Investigator: Gary Steinberg, MD         
St. Joseph's Medical Center Recruiting
Stockton, California, United States, 95204
Contact: Teri Kozik    209-461-5374    teri.kozik@dignityhealth.org   
Principal Investigator: Venkata Emani, MD         
United States, Colorado
St. Mary's Medical Center Recruiting
Grand Junction, Colorado, United States, 81501
Contact: Lisa Bertrand    970-298-6575    Lisa.Bertrand@sclhs.net   
Principal Investigator: Logan McDaneld, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Michelle Klenotic, RN    860-972-5647    michelle.klenotic@hhchealth.org   
Principal Investigator: Akhilesh Jain, MD         
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jackie Gamberdella    203-737-1899    jacqueline.gamberdella@yale.edu   
Principal Investigator: Carlos Mena-Hurtado, MD         
United States, District of Columbia
Washington Hospital Center/Medstar Recruiting
Washington, District of Columbia, United States, 20010
Contact: Suman Singh    202-877-8475      
Principal Investigator: Edward Woo, MD         
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Shawna Miller    727-461-8885    shawna.miller@baycare.org   
Principal Investigator: Eric Lopez del Valle, MD         
University of Florida Health at Shands Recruiting
Gainesville, Florida, United States, 32610
Contact: Ether Olasoji    352-273-6448    Esther.Olasoji@neurology.ufl.edu   
Principal Investigator: Anna Khanna, MD         
Lyerly Neurosurgery Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Ebreo    904-202-7063    nancy.ebreo@bmcjax.com   
Principal Investigator: Ricardo Hanel, MD         
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32216
Contact: Mary Hudson    904-493-3333 ext 1049    mhudson@firstcoastcardio.com   
Principal Investigator: Vaqar Ali, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Sebrina Selman    904-953-3062    Selman.Sabrina@mayo.edu   
Principal Investigator: Albert Hakaim, MD         
Mount Sinai Medical Center of Florida Recruiting
Miami Beach, Florida, United States, 33140
Contact: Yoselin Lugo    305-674-2121 ext 59162    yoselin.lugo@msmc.com   
Principal Investigator: Robert Beasley, MD         
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Andrea Escobar    305-243-8876    aescobar@med.miami.edu   
Principal Investigator: Dileep Yavagal, MD         
Miami Cardiac and Vascular Institute at Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Ivette Cruz    786-596-4746    ivettec@baptisthealth.net   
Principal Investigator: Barry Katzen, MD         
Cardiovascular Institute of Northwest Florida Recruiting
Panama City, Florida, United States, 32401
Contact: Marcy McElhaney    850-769-0329    marcy1research@gmail.com   
Principal Investigator: Amir Haghighat, MD         
Tampa General Hospital /University of South Florida Active, not recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Missy Dinos, RN    404-727-8340    missy.maton@emory.edu   
Principal Investigator: Yazan Duwayri, MD         
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Cedric McKoy    773-834-7854    Cedric.McKoy@uchospitals.edu   
Principal Investigator: James Brorson, MD         
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Lillian Toaspern    312-695-3410    lillian.toaspern@northwestern.edu   
Principal Investigator: Mark Eskandari, MD         
Loyola University Medical Center Active, not recruiting
Maywood, Illinois, United States, 60135
Prairie Heart/St. John's Hospital Recruiting
Springfield, Illinois, United States, 62701
Contact: Lauren Mcneil Bainter    217-492-9100 ext 142    lmcneil@prairieresearch.com   
Principal Investigator: Jeffrey Goldstein, MD         
United States, Indiana
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Stephanie Alford    317-893-1712    stephanie.alford@franciscanalliance.org   
Principal Investigator: William Berg, MD         
The Heart Group, PC Recruiting
Newburgh, Indiana, United States, 47630
Contact: Amanda Johnson    812-490-4505    amanda.johnson@deaconess.com   
Principal Investigator: Simon Tran, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Heena Olalde    319-356-8326    heena-olalde@uiowa.edu   
Principal Investigator: Mel Sharafuddin, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Tilitha Shawgo    913-588-9720    tshawgo@kumc.edu   
Principal Investigator: Kamal Gupta, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Linda Breathitt    859-260-6344    lbreathitt@bhsi.com   
Contact: Sara Renfrow    859-260-6950    sara.renfrow@bhsi.com   
Principal Investigator: Michael Jones, MD         
University of Louisville Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Active, not recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Shannon Williams    504-842-6487    slwilliams@ochsner.org   
Principal Investigator: Charles Sternbergh III, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Debbie Cushing    207-885-4438    cushid@mmc.org   
Principal Investigator: Robert Ecker, MD         
United States, Maryland
University of Maryland VA Recruiting
Baltimore, Maryland, United States, 21201
Contact: Francesca Montellanos    410-706-2143    FMontellanos@som.umaryland.edu   
Principal Investigator: Shahab Toursavadkohi, MD         
John Hopkins Medical Institution Active, not recruiting
Baltimore, Maryland, United States, 21224
Adventist HealthCare/ Washington Adventist Hospital Recruiting
Takoma Park, Maryland, United States, 20912
Contact: Tamika Magee    301-891-5493    tmagee@adventisthealthcare.com   
Principal Investigator: Fayaz Shawl, MD         
United States, Massachusetts
St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
Contact: Margaret Michaelian    617-789-3041    Margaret.michaelian@steward.org   
Principal Investigator: Lawrence Garcia, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Contact: Devil Qualls    617-726-4271    dqualls@mgh.harvard.edu   
Principal Investigator: Scott Silverman, MD         
Beth Israel Deaconess Medical Center (BIDMC) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Joanna Sullivan    617-632-7488    jsulli20@bidmc.harvard.edu   
Principal Investigator: Marc Schermerhorn, MD         
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Karen Belanger    734-845-5685    karen.belanger@va.gov   
Principal Investigator: Peter Henke, MD         
University of Michigan Hospital and Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Susan Blackburn    734-936-8556    susablac@med.umich.edu   
Principal Investigator: Nicholas Osborne, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Crystal Bradley    313-916-1011    cbradle4@hfhs.org   
Principal Investigator: Mitchell Weaver, MD         
Michigan Vascular Center/McLaren- Flint Recruiting
Flint, Michigan, United States, 48532
Contact: Maureen Blewett    810-600-2009    maureena@michiganvascular.com   
Principal Investigator: Robert Molnar, MD         
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Contact: Heidi Taylor    517-364-5734    heidi.taylor@sparrow.org   
Principal Investigator: Joel Cohn, MD         
Cardiac and Vascular Research Center of Northern Michigan/McLaren Northern Michigan Recruiting
Petoskey, Michigan, United States, 49770
Contact: Jennifer LaLonde    231-487-9185    jlalonde@cvrcnm.com   
Principal Investigator: Jason Ricci, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Mary Zajechowski, RN       Mary.Zajechowski@beaumont.org   
Principal Investigator: O. William Brown, MD         
Trinity Health/ Michigan Heart Active, not recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minneapolis Clinic of Neurology, Ltd./ North Memorial Medical Center Recruiting
Golden Valley, Minnesota, United States, 55422
Contact: Cassandra Higgins, MD    763-302-4026    Cassandra.Higgins@Mpls-clinic.com   
Principal Investigator: Irfan Altafullah, MD         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Amanda Weller    612-301-1593    andy0003@umn.edu   
Principal Investigator: Tapan Thacker, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Amanda Weller    612-301-1593    andv0003@umn.edu   
Principal Investigator: Mustapha Ezzeddine, MD         
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bambi Wessel    507-293-1963    Wessel.Bambi@mayo.edu   
Principal Investigator: Giuseppe Lanzino, MD         
St. Cloud Hospital Active, not recruiting
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Mercy Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Camilla Cook    314-251-3779    camilla.cook2@mercy.net   
Principal Investigator: Scott Westfall, MD         
Mercy Medical Research Institute Active, not recruiting
Springfield, Missouri, United States, 65807
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Jana Tancredi    551-996-2353    Jana.tancredi@hackenackmeridian.org   
Principal Investigator: Massimo Napolitano, MD         
United States, New York
SUNY Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Hartney    716-929-9651    mhartney@ubns.com   
Principal Investigator: Adnan Siddiqui, MD         
Mount Sinai Hospital New York Recruiting
New York, New York, United States, 10029
Contact: Ricardo Renvill    212-241-2220    ricardo.renvill@mssm.edu   
Principal Investigator: Stanley Tuhrim, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Alberto Canaan    212-342-1491    aac23@cumc.columbia.edu   
Principal Investigator: Randolph Marshall, MD         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Carla Sherman, RN    212-746-6757    cas9149@med.cornell.edu   
Principal Investigator: Dana Leifer, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago    516-562-6763    lyn.santiago@chsli.org   
Principal Investigator: George Petrossian, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Nicole Longoria    919-668-1419    nicole.longoria@duke.edu   
Principal Investigator: Richard McCann, MD         
North Carolina Heart & Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Vanessa Moore    919-784-7850    Vanessa.Moore@unchealth.unc.edu   
Principal Investigator: Ravish Sachar, MD         
Coastal Carolina Surgical Associates PA Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Tracy Helm    910-343-0811    tsmith@coastalsurgery.com   
Principal Investigator: David Weatherford, MD         
Novant Health/Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Maureen Dosunmu    336-718-6087    modosunmu@novanthealth.org   
Principal Investigator: Donald Heck, MD         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Myra Suarez    336-713-2661    msuarez@wakehealth.edu   
Principal Investigator: Cheryl Bushnell, MD         
United States, Ohio
University of Cincinnati Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45219
Louis Stokes Cleveland VA Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Deborah Nogle    216-791-3800 ext 6961    Deborah.Nogle@va.gov   
Principal Investigator: Gilles Pinault, MD         
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Deanna Grenig    216-844-2984    Deanna.Grenig@UHhospitals.org   
Contact: Kyle Dexter    216-844-2984    Kyle.Dexter@UHhospitals.org   
Principal Investigator: Vikram Kashyap, MD         
Ohio State Medical Center Recruiting
Columbia, Ohio, United States, 43210
Contact: Isac Kunnath    614-292-4963    Isac.Kunnath@osumc.edu   
Principal Investigator: Jean Starr, MD         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Lindsey Sikora    614-566-1258    Lindsey.Sikora@ohiohealth.com   
Principal Investigator: Gary Ansel, MD         
Jobst Vascular Institute/Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Joan Bick    419-291-2132    joan.bick@promedica.org   
Principal Investigator: Todd Russell, MD         
Mercy Health St.Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Melissa Thomas       mthomas@mercy.com   
Principal Investigator: Osama Zaidat, MD         
United States, Oklahoma
St. John Clinical Research Institute Active, not recruiting
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Providence Brain and Spine Institute Recruiting
Portland, Oregon, United States, 97225
Contact: Kyla Lindberg    503-216-1191    Kyla.Lindberg@providence.org   
Principal Investigator: Theodore Lowenkopf, MD         
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jon Foley    503-494-8001    foley@ohsu.edu   
Principal Investigator: Wayne Clark, MD         
United States, Pennsylvania
Lehigh Valley Hospital - Network Office of Research Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Cheryl Gumulak    610-402-9543    Cheryl_D.Gumulak@lvhn.org   
Principal Investigator: John Castaldo, MD         
Doylestown Hospital Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Deborah Wood    215-345-2556    dwood@dh.org   
Principal Investigator: Steven Guidera, MD         
UPMC Hamot Recruiting
Erie, Pennsylvania, United States, 16550
Contact: Patty Henry    814-877-3635    henrypc@upmc.edu   
Principal Investigator: Richard Petrella, MD         
PennState Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17018
Contact: Deborah Hoffman    717-531-0003 ext 283063    dhoffman1@pennstatehealth.psu.edu   
Principal Investigator: Scott Simon, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nichole Gallatti    215-349-8651    nichole.gallatti@uphs.upenn.edu   
Principal Investigator: Michael Mullen, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jaime Dougherty    215-955-7962    jaime.dougherty@jefferson.edu   
Principal Investigator: Pascal Jabbour, MD         
UPMC Presbyterian University Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Cathy Van Every    412-647-7099    vaneverycc@upmc.edu   
Principal Investigator: Lawrence Wechsler, MD         
Pinnacle Health Cardiovascular Institute Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Gretchen Meise, RN    717-920-4400 ext 4280    gmeise@pinnaclehealth.org   
Principal Investigator: William Bachinsky, MD         
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Susan Herring    484-476-8514    HerringS@mlhs.org   
Principal Investigator: William Gray, MD         
Berks Cardiologists / St. Joseph's Medical Center Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact: Kim Petersheim, RN, BSN    610-685-4843    kpetersheim@berkscardiologists.com   
Principal Investigator: Guy N. Piegari, MD         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Lina Felix    401-793-4105    lfelix@lifespan.org   
Principal Investigator: Herbert Aronow, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Vicki Streets    843-792-8606    streetsv@musc.edu   
Principal Investigator: Christine Holmstedt, MD         
United States, South Dakota
North Central Heart Institute Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Patty Eisenbraun    605-977-5336    peisenbraun@ncheart.com   
Principal Investigator: Michael Bacharach, MD         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Josh Lester    423-230-5642    jlester@mycva.com   
Principal Investigator: Chris Metzger, MD         
Tennova Healthcare/ Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Nancy Bradley    865-218-7538    nancy.bradley@tennova.com   
Principal Investigator: Malcolm Foster, MD         
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38017
Contact: Vanessa Derrick    901-226-1689    vanessa.derrick@bmhcc.org   
Principal Investigator: Adam Arthur, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Morgan Pittman    970-581-2258    morgan.a.pittman@vanderbilt.edu   
Principal Investigator: Michael Froehler, MD         
United States, Texas
Seton Medical Center Austin Active, not recruiting
Austin, Texas, United States, 78705
Cardiothoracic and Vascular Surgeons Active, not recruiting
Austin, Texas, United States, 78756
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Marilisa Soto    469-449-3466    marilisasotoglez@gmail.com   
Principal Investigator: Gregory Modrall, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: David McCane    713-441-5801    dmccane@houstonmethodist.org   
Principal Investigator: David Chiu, MD         
Memorial Hermann Texas Medical Center Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Kristin Konery    801-507-4798    kristin.konery@imail.org   
Principal Investigator: Lee Burke, MD         
University of Utah Hospitals and Clinics Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kinga Aitken    801-581-5523    kinga.aitken@hsc.utah.edu   
Principal Investigator: Jennifer Majersik, MD         
George E. Wahlen Department of Veterans Affairs Medical Center Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Kinga Aitken    801-581-5523    kinga.aitken@hsc.utah.edu   
Principal Investigator: Jana Wold, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Caryn Wolf    434-924-9271    clw8pv@virginia.edu   
Principal Investigator: Avery Evans, MD         
Inova Fairfax Health Care Recruiting
Falls Church, Virginia, United States, 22042
Contact: Mallory Frazier    703-776-8085    mallory.frazier@inova.org   
Principal Investigator: Dipankar Mukherjee, MD         
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Contact: Ashley Zelaski    540-536-7542    azelaski@valleyhealthlink.com   
Principal Investigator: Dan-Victor Giurgiutiu, MD         
United States, Washington
Overlake Hospital Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Kimberly Glorieux    425-635-6082    Kimberly.Glorieux@overlakehospital.org   
Principal Investigator: Kathleen Gibson, MD         
University of Washington Medicine-Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Wendy Haugen    206-744-3938    haugenw@uw.edu   
Principal Investigator: David Tirschwell, MD         
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Susan Bigda    206-277-4681    susan.bigda@va.gov   
Principal Investigator: Gale Tang, MD         
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
Providence Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Katie Crawford    509-474-4302    Katie.Crawford@providence.org   
Principal Investigator: Philip Huber, MD         
United States, Wisconsin
Gundersen Clinic, Ltd Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Sara Meyers    608-775-0238    srmeyers@gundersenhealth.org   
Principal Investigator: Mouhammed Kabbani, MD         
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kaelin Grant    608-262-1551    grantk@surgery.wisc.edu   
Principal Investigator: Girma Tefera, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Geni Maclean, RN    604-875-4554    genoveva@bcstrokecentre.ca   
Principal Investigator: Philip Teal, MD         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Yangmei Li    416-864-6060 ext 3444    liya@smh.ca   
Principal Investigator: Tom Marotta, MD         
St. Boniface Hospital Recruiting
Winnipeg, Ontario, Canada, R2H 2A6
Contact: Wendy Weighell    204-235-3916    wweighell@sbgh.mb.ca   
Principal Investigator: Randolph Guzman, MD         
Canada, Quebec
CHU de Québec/ Hôpital de l'Enfant-Jésus Recruiting
Québec City, Quebec, Canada, G1J1Z4
Contact: Annette Hache    418-649-5892    annette.hache.cha@ssss.gouv.qc.ca   
Principal Investigator: Ariane Mackey, MD         
Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Spain
Contact: Martha Vargas    +932272118    mvargas@clinic.ub.es   
Principal Investigator: Angel Chamorro, MD         
Sponsors and Collaborators
Thomas G. Brott, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Thomas G. Brott, MD Mayo Clinic Florida
Principal Investigator: James F. Meschia, MD Mayo Clinic Florida
Principal Investigator: Brajesh K. Lal, MD University of Maryland
Principal Investigator: George Howard, DrPH University of Alabama at Birmingham

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Thomas G. Brott, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02089217     History of Changes
Other Study ID Numbers: 13-004051
U01NS080168 ( U.S. NIH Grant/Contract )
IDE: G130221 ( Other Identifier: FDA )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thomas G. Brott, M.D., Mayo Clinic:
asymptomatic
carotid
stent
endarterectomy
embolic protection
medical management
hypertension
hyperlipidemia
cognition
risk factor control

Additional relevant MeSH terms:
Layout table for MeSH terms
Constriction, Pathologic
Carotid Stenosis
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases