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| Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00004732 |
Purpose
The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Cerebral Infarction Carotid Stenosis Atherosclerosis |
Procedure: carotid endarterectomy Procedure: carotid angioplasty with stenting |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
| Official Title: | Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) |
| Estimated Enrollment: | 2500 |
| Study Start Date: | December 2000 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Procedure: carotid endarterectomy
CEA involves a neck incision and physical removal of the plaque from the inside of the artery.
|
| 2: Active Comparator |
Procedure: carotid angioplasty with stenting
CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
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The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Stents are medical devices approved and commonly used for treatment of heart disease. The stent that will be used in this trial is the ACCULINK(TM) Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.
The RX ACCUNET(TM) Embolic Protection System (an umbrella-like device that expands above the narrowed portion of the carotid artery) will be used in conjunction with the RX ACCULINK stent. The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure. Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain. The RX ACCUNET System is closed and removed after the stent is placed.
CEA involves a neck incision and physical removal of the plaque from the inside of the artery. CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck.
The stent is then placed to cover the plaque and hold the artery open. Participants will be randomly assigned to undergo either CAS or CEA, and all patients will receive best medical management, which includes treatment with aspirin, treatment of high blood pressure, and treatment of other stroke risk factors. Participants will be followed for up to four years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 117 Study Locations| Principal Investigator: | Thomas G. Brott, M.D. | Mayo Clinic and University of Medicine and Dentistry New Jersey |
More Information
| Responsible Party: | Mayo Clinic and University of Medicine and Dentistry New Jersey ( Thomas G. Brott, MD, Principal Investigator ) |
| Study ID Numbers: | R01NS38384 |
| Study First Received: | February 25, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004732 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
surgery stenting CREST Stroke Cerebral Infarction carotid endarterectomy |
carotid stenting revascularization angioplasty stenosis atherosclerosis |
|
Atherosclerosis Arterial Occlusive Diseases Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Constriction, Pathologic Ischemia Arteriosclerosis |
Brain Diseases Cerebrovascular Disorders Carotid Stenosis Necrosis Brain Ischemia Brain Infarction Infarction Carotid Artery Diseases |
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Atherosclerosis Arterial Occlusive Diseases Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia Arteriosclerosis Brain Diseases |
Cerebrovascular Disorders Carotid Stenosis Necrosis Pathologic Processes Brain Ischemia Cardiovascular Diseases Brain Infarction Infarction Carotid Artery Diseases |
