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| Descriptive Information Fields | |||||
| Brief Title † | Carotid Revascularization Endarterectomy Versus Stenting Trial | ||||
| Official Title † | Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) | ||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Open Label, Parallel Assignment | ||||
| Primary Outcome Measure † | If the efficacy of CAS differs from CEA in preventing stroke, myocardial infarction & death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic/asymptomatic extracranial carotid stenosis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Stroke Cerebral Infarction Carotid Stenosis Atherosclerosis |
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| Intervention † | Procedure: carotid endarterectomy Procedure: carotid angioplasty with stenting |
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| MEDLINE PMIDs | |||||
| Links | CREST study website ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 2500 | ||||
| Start Date † | December 2000 | ||||
| Completion Date | December 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004732 | ||||
| Organization ID | R01NS38384 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Medicine and Dentistry New Jersey | ||||
| Collaborators †† | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Investigators † |
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| Information Provided By | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | February 25, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||