Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:35 - Any
Updated:4/17/2018
Start Date:December 2014
End Date:December 2020
Contact:CREST-2 Administrative Center
Phone:844-956-1826

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
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Little Rock, Arkansas 72205
Principal Investigator: Mohammed Moursi, MD
Phone: 501-257-6906
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Yazan Duwayri, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Phone: 205-934-3131
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Scott Silverman, MD
Phone: 617-643-5827
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
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Phone: 513-503-5284
University of Cincinnati Medical Center Opening in 1823 as the country
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Mel Sharafuddin, MD
Phone: 319-356-8326
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4201 Belfort Road
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8700 Beverly Blvd # 8211
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(1-800-233-2771)
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
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3400 Spruce St
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 (215) 662-4000
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22 Bramhall St
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3181 Southwest Sam Jackson Park Road
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1660 South Columbian Way
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10 North Greene Street
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Buffalo, New York 14209
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlottesville, Virginia 22903
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1215 Lee St
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5841 S Maryland Ave
Chicago, Illinois 60637
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Clearwater, Florida 33756
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Principal Investigator: Gilles Pinault, MD
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Columbia, Ohio 43210
Principal Investigator: Jean Starr, MD
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1801 Inwood Rd
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(214) 645-3300
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2301 Erwin Rd
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919-684-8111
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Falls Church, Virginia 22042
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5020 West Bristol Road
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30 Prospect Ave
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(201) 996-2000
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80 Seymour St
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500 University Drive
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6550 Fannin St
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Jacksonville, Florida 32207
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Kamal Gupta, MD
Phone: 913-588-9720
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Kingsport, Tennessee 37660
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Lexington, Kentucky 40503
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Los Angeles, California 90033
Principal Investigator: Fred Weaver, MD
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Los Angeles, California 90095
Principal Investigator: Wesley Moore, MD
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Los Angeles, California 90027
Principal Investigator: Navdeep Sangha, MD
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Wei Liu, MD
Phone: 502-852-5251
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Madison, Wisconsin 53792
(608) 263-2400
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Camilo Gomez, MD
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Memphis, Tennessee 38120
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Miami, Florida 33176
Principal Investigator: Barry Katzen, MD
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Seemant Chaturvedi, MD
Phone: 305-243-8876
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Miami Beach, Florida 33140
Principal Investigator: Robert Beasley, MD
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Minneapolis, Minnesota 55414
Principal Investigator: Tapan Thacker, MD
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Lee Burke, MD
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20 York St, N20 York St,
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(203) 688-4242
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New Orleans, Louisiana 70112
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New Orleans, Louisiana 70121
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Randolph Marshall, MD
Phone: 212-342-1491
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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New York, New York 10021
Principal Investigator: Dana Leifer, MD
Phone: 212-746-6757
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from
New York, NY
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New York, New York 10029
Principal Investigator: Stanley Tuhrim, MD
Phone: 212-241-2220
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from
New York, NY
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Newburgh, Indiana 47630
Principal Investigator: Simon Tran, MD
Phone: 812-490-4505
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from
Newburgh, IN
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3801 Miranda Avenue
Palo Alto, California 94304
650-493-5000
Principal Investigator: Oliver Aalami, MD
Phone: 650-849-0357
VA Palo Alto Health Care System The VA Palo Alto Health Care System (VAPAHCS) consists...
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Palo Alto, CA
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Panama City, Florida 32401
Principal Investigator: Amir Haghighat, MD
Phone: 850-769-0329
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Panama City, FL
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Petoskey, Michigan 49770
Principal Investigator: Jason Ricci, MD
Phone: 231-487-9185
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Petoskey, MI
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Pascal Jabbour, MD
Phone: 215-503-4852
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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from
Philadelphia, PA
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Phoenix, Arizona 85054
Principal Investigator: Bart Demaerschalk, MD
Phone: 480-342-1316
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Phoenix, AZ
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Phoenix, Arizona 85006
Principal Investigator: Venkatesh Ramaiah, MD
Phone: 602-604-5021
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Phoenix, AZ
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Phoenix, Arizona 85013
Principal Investigator: Joseph Zabramski, MD
Phone: 602-406-6267
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Lawrence Wechsler, MD
Phone: 412-647-7099
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Pittsburgh, PA
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Portland, Oregon 97225
Principal Investigator: Theodore Lowenkopf, MD
Phone: 503-216-1191
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Portland, OR
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Herbert Aronow, MD
Phone: 401-793-4105
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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from
Providence, RI
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Raleigh, North Carolina 27607
Principal Investigator: Ravish Sachar, MD
Phone: 919-784-7850
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Raleigh, NC
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Giuseppe Lanzino, MD
Phone: 507-293-1963
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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Roslyn, New York 11576
Principal Investigator: George Petrossian, MD
Phone: 516-562-6763
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Roslyn, NY
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Royal Oak, Michigan 48073
Principal Investigator: O. William Brown, MD
Phone: 248-551-0194
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Royal Oak, MI
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
Principal Investigator: Fareed K Suri, MD
Phone: 320-255-5772
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Saint Cloud, MN
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Saint Louis, Missouri 63141
Principal Investigator: Scott Westfall, MD
Phone: 314-251-5916
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Saint Louis, MO
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Salt Lake City, Utah 84132
Principal Investigator: Jennifer Majersik, MD
Phone: 801-581-5523
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from
Salt Lake City, UT
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Salt Lake City, Utah 84148
Principal Investigator: Jana Wold, MD
Phone: 801-581-5523
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Salt Lake City, UT
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