NCT00004732
Carotid Revascularization Endarterectomy Versus Stenting Trial
NA
COMPLETED
NCT00004732
INTERVENTIONAL
Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
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).
Inclusion Criteria:
* Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than or equal to 50% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 70% by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) are eligible for randomization.
* Asymptomatic patients with no recent (in the last 6 months) neurological events referable to the study with artery and carotid stenosis (patients with symptoms beyond 180 days are considered asymptomatic) greater than or equal to 60% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 80% by CTA or MRA are eligible for randomization.
Exclusion Criteria:
* Conditions that: (1) interfere with the evaluation of endpoints, (2) are known to interfere with the completion of CEA or CAS, or (3) affect the likelihood of survival for the study period (4 years). Chronic atrial fibrillation and/or anti-coagulation or episodic atrial fibrillation within the last 6 months.
Atherosclerosis
Stroke
Carotid Stenosis
Cerebral Infarction
Myocardial Infarction
- PREVENTION
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- Type: PROCEDURE
- Name: Carotid Endarterectomy (CEA)
- Description: CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
- Arm Group Labels: Carotid Artery Endarterectomy (CEA)
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- Type: DEVICE
- Name: Carotid Artery Stenting (CAS)
- Description: 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. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.
- Arm Group Labels: Carotid Artery Stenting (CAS)
- Rutgers, The State University of New Jersey