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Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
This study is ongoing, but not recruiting participants.
Study NCT00004732   Information provided by University of Medicine and Dentistry New Jersey
First Received: February 25, 2000   Last Updated: August 4, 2009   History of Changes

February 25, 2000
August 4, 2009
December 2000
December 2011   (final data collection date for 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 ]
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.
Complete list of historical versions of study NCT00004732 on ClinicalTrials.gov Archive Site
 
 
 
Carotid Revascularization Endarterectomy Versus Stenting Trial
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).

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.

Phase III
Interventional
Prevention, Randomized, Open Label, Parallel Assignment
  • Stroke
  • Cerebral Infarction
  • Carotid Stenosis
  • Atherosclerosis
  • Procedure: carotid endarterectomy
  • Procedure: carotid angioplasty with stenting
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2500
December 2011
December 2011   (final data collection date for primary outcome measure)

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 CTA or 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00004732
Thomas G. Brott, MD, Principal Investigator, Mayo Clinic and University of Medicine and Dentistry New Jersey
0119970017
University of Medicine and Dentistry New Jersey
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Thomas G. Brott, M.D. Mayo Clinic and University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP