The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

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

Description:

The purpose of this trial is to determine the most effective treatment method to prevent strokes in people who have narrowing in the carotid artery but no stroke symptoms caused by the blockage of that artery.

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.

CREST-2 consists of 2 parallel, randomized clinical trials.  One trial will compare intensive medical management to carotid endarterectomy plus intensive medical management.  The parallel trial will compare intensive medical management to carotid artery stenting plus intensive medical management. Intensive medical management will involve a lifestyle intervention to monitor and manage risk factors such as blood pressure, cholesterol, smoking cessation, weight loss, and physical activity.

An estimated 2480 participants will be enrolled in CREST-2 at approximately 150 sites in the United States and internationally.  Each eligible participant will be evaluated to determine which procedure is best for him/her.  All participants will receive intensive medical treatment.  Participants will remain in the study up to 4 years.  Participants will receive $95 for each scheduled visit.

Eligibility Criteria:

Selected Eligibility 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 transient ischemic attack (TIA) ipsilateral to the stenosis within 180 days of randomization. Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent.
  4. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
  5. Carotid stenosis must be treatable with carotid endarterectomy (CEA), carotid artery stenting (CAS), or either procedure.

General Exclusion Criteria

  1. Gastrointestinal (GI) hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy.
  2. Major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes.
  3.  History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation.
  4.  Neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
  5. Patient objects to future blood transfusions.
  6. Platelet count <100,000/μl or history of heparin-induced thrombocytopenia.
  7. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents.
  8. Chronic atrial fibrillation or any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation.
  9. 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 cm), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism.
  10. 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).
  11. Ejection fraction <30% or admission for heart failure in prior 6 months.
  12. Respiratory insufficiency with life expectancy < 4 years or forced expiratory volume (FEV1) < 30% of predicated value.
  13. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min.
  14. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy).
  15. Previous ipsilateral CEA or CAS, or ipsilateral internal or common carotid artery occlusion.
  16. Intra-carotid floating thrombus.
  17. Ipsilateral intracranial aneurysm > 5 mm not successfully treated with clipping, coiling, or flow diversion.

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Location:

Multiple U.S. Locations

Study Website:

Clinicaltrials.gov website