Clinical trial NCT02089217: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Official title: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carotid Stenosis
Keywords: asymptomatic
carotid
stent
endarterectomy
embolic protection
medical management
hypertension
hyperlipidemia
cognition
risk factor control
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-03-17
Enrollment: 2486
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: General Inclusion Criteria

1. Patients ≥35 years old.
2. Carotid stenosis defined as:

   * Stenosis ≥70% by catheter angiography (NASCET Criteria); OR
   * by Doppler ultrasonography (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. computed tomography angiography (CTA) with ≥ 70% stenosis, or
     4. magnetic resonance angiography (MRA) with ≥ 70% stenosis.
3. No medical history of stroke or transient ischemic attack (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).
4. Patients must have a modified Rankin Scale (mRS) 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 carotid endarterectomy (CEA), carotid artery stenting (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, unless the patient has had successful atrial appendage closure (e.g., Watchman Device) and no longer requires chronic therapeutic anticoagulation.
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 patent foramen ovale (PFO) with prior paradoxical embolism.
14. Unstable angina defined as rest angina with electrocardiogram (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 forced expiratory volume (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 glomerular filtration rate (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 common carotid artery (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 internal carotid artery (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, computed tomography (CT), magnetic resonance (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.

Primary outcomes:
measure: Stroke and death
timeFrame: 4 years
Secondary outcomes:
measure: Cognitive Function
timeFrame: 4 years
measure: Major Stroke
timeFrame: 4 years
measure: Effect modification
timeFrame: 4 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Cardiovascular Associates/Brookwood Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital/ Heart Center Research Alabama
state: Alabama
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
state: Arizona
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Scottsdale Osborn Medical Center
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Fremont
country: United States
facility: Mission Cardiovascular Research
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Torrance
country: United States
facility: Providence Little Company of Mary Medical Center
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Medical Center
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar/Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health at Shands
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery
state: Florida
city: Jacksonville
country: United States
facility: UF Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute at Baptist Hospital of Miami
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Tampa
country: United States
facility: Tampa General/University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Carbondale
country: United States
facility: Southern Illinois Healthcare
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Rockford
country: United States
facility: Mercy Health Riverside
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart/St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Heart Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Heart and Vascular
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland VA
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins Medical Institution
state: Maryland
city: Takoma Park
country: United States
facility: White Oak Medical Center
state: Maryland
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Hospital and Health Systems
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center/McLaren- Flint
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan/McLaren Northern Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health/Michigan Heart
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology, Ltd./North Memorial Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: John Cochran VA Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: SUNY Buffalo
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute of Medical Research/Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital New York
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Syracuse
country: United States
facility: Crouse Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart & Vascular Research
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Carolina Surgical Associates PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health/Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbia
country: United States
facility: Ohio State Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute/University of Toledo
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St.Vincent Medical Center
state: Ohio
city: Tulsa
country: United States
facility: St. John Clinical Research Institute
state: Oklahoma
city: Portland
country: United States
facility: Providence Brain and Spine Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital - Network Office of Research
state: Pennsylvania
city: Altoona
country: United States
facility: UPMC Altoona
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists / St. Joseph's Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Kingsport
country: United States
facility: CVA Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare/ Turkey Creek Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Seton Medical Center Austin
state: Texas
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: Salt Lake City
country: United States
facility: George E. Wahlen Department of Veterans Affairs Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Health Care
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington Medicine-Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospitals & Clinics
state: Wisconsin
city: Perth
country: Australia
facility: Fiona Stanley Hospital
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Ontario
city: Québec City
country: Canada
facility: CHU de Québec/ Hôpital de l'Enfant-Jésus
state: Quebec
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka University Vascular Surgery
city: Haifa
country: Israel
facility: Rambam Healthcare
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Shaare-Zedek Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Mayo Clinic
name: James F. Meschia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Brajesh K. Lal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: George Howard, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Lloyd Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamtchum-Tatuene J, Saba L, Heldner MR, Poorthuis MHF, de Borst GJ, Rundek T, Kakkos SK, Chaturvedi S, Topakian R, Polak JF, Jickling GC; Carotid Atherosclerosis and Stroke Collaboration (CASCO). Interleukin-6 Predicts Carotid Plaque Severity, Vulnerability, and Progression. Circ Res. 2022 Jul 8;131(2):e22-e33. doi: 10.1161/CIRCRESAHA.122.320877. Epub 2022 Jun 17.
citation: Lazar RM, Wadley VG, Myers T, Jones MR, Heck DV, Clark WM, Marshall RS, Howard VJ, Voeks JH, Manly JJ, Moy CS, Chaturvedi S, Meschia JF, Lal BK, Brott TG, Howard G. Baseline Cognitive Impairment in Patients With Asymptomatic Carotid Stenosis in the CREST-2 Trial. Stroke. 2021 Dec;52(12):3855-3863. doi: 10.1161/STROKEAHA.120.032972. Epub 2021 Aug 26.
citation: Haley W, Shawl F, Charles Sternbergh W 3rd, Turan TN, Barrett K, Voeks J, Brott T, Meschia JF. Non-Adherence to Antihypertensive Guidelines in Patients with Asymptomatic Carotid Stenosis. J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105918. doi: 10.1016/j.jstrokecerebrovasdis.2021.105918. Epub 2021 Jun 18.
citation: Turan TN, Meschia JF, Chimowitz MI, Roldan A, LeMatty T, Luke S, Breathitt L, Eiland R, Foley J, Brott TG. Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial. J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105362. doi: 10.1016/j.jstrokecerebrovasdis.2020.105362. Epub 2020 Sep 30.
citation: Turan TN, Voeks JH, Chimowitz MI, Roldan A, LeMatty T, Haley W, Lopes-Virella M, Chaturvedi S, Jones M, Heck D, Howard G, Lal BK, Meschia JF, Brott TG. Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial. Stroke. 2020 Oct;51(10):2960-2971. doi: 10.1161/STROKEAHA.120.030730. Epub 2020 Sep 21.
citation: Lal BK, Meschia JF, Roubin GS, Jankowitz B, Heck D, Jovin T, White CJ, Rosenfield K, Katzen B, Dabus G, Gray W, Matsumura J, Hopkins LN, Luke S, Sharma J, Voeks JH, Howard G, Brott TG; CREST-2 Investigators. Factors influencing credentialing of interventionists in the CREST-2 trial. J Vasc Surg. 2020 Mar;71(3):854-861. doi: 10.1016/j.jvs.2019.05.035. Epub 2019 Jul 26.
citation: Musialek P, Roubin GS. Commentary: Double-Layer Carotid Stents: From the Clinical Need, through a Stent-in-Stent Strategy, to Effective Plaque Isolation... the Journey Toward Safe Carotid Revascularization Using the Endovascular Route. J Endovasc Ther. 2019 Aug;26(4):572-577. doi: 10.1177/1526602819861546. No abstract available.
citation: Lal BK, Meschia JF, Brott TG. Clinical need, design, and goals for the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis trial. Semin Vasc Surg. 2017 Mar;30(1):2-7. doi: 10.1053/j.semvascsurg.2017.04.004. Epub 2017 Apr 27.
citation: Demaerschalk BM, Brown RD Jr, Roubin GS, Howard VJ, Cesko E, Barrett KM, Longbottom ME, Voeks JH, Chaturvedi S, Brott TG, Lal BK, Meschia JF, Howard G; CREST-2 Investigators. Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial. Stroke. 2017 Sep;48(9):2511-2518. doi: 10.1161/STROKEAHA.117.016976. Epub 2017 Aug 2.
citation: Howard VJ, Meschia JF, Lal BK, Turan TN, Roubin GS, Brown RD Jr, Voeks JH, Barrett KM, Demaerschalk BM, Huston J 3rd, Lazar RM, Moore WS, Wadley VG, Chaturvedi S, Moy CS, Chimowitz M, Howard G, Brott TG; CREST-2 study investigators. Carotid revascularization and medical management for asymptomatic carotid stenosis: Protocol of the CREST-2 clinical trials. Int J Stroke. 2017 Oct;12(7):770-778. doi: 10.1177/1747493017706238. Epub 2017 May 2.