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Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00004732
First received: February 25, 2000
Last updated: January 25, 2013
Last verified: January 2013
History of Changes

February 25, 2000
January 25, 2013
December 2000
February 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: 4 years ] [ Designated as safety issue: Yes ]
Although 4-year follow-up data was used to assess the primary endpoint, the published results were based on a median follow-up period of 2.5 years.
Not Provided
Complete list of historical versions of study NCT00004732 on ClinicalTrials.gov Archive Site
  • To describe differential efficacy of CAS and CEA in male and female participants. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • To evaluate differences in measures of health related quality of life and cost effectiveness. [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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 RX(Rapid Exchange) 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 ten years.

With the simplification of the protocol for long-term follow-up, the focus for secondary outcomes is to assess restenosis and viability of the procedure. Restenosis rates on an annual basis in both the endarterectomy and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually (standard of care).

In addition to restenosis, the "viability" of the procedures will be assessed by the need (or lack of need) for repeat revascularization (either open surgical or endovascular) after the index procedure. The question "has a new carotid intervention been performed since last follow-up" will be asked at every contact with the patient. If answered positively, additional data will be collected on the appropriate CRFs (case report forms).

LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICARE AND MEDICAID ADMINISTRATIVE DATA

The purpose of linking Medicare-eligible CREST participants with CMS (Center for Medicaid & Medicare Services) data files is to assess patient outcomes and utilization of health care services. This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies, as well as explore alternative strategies to ascertain patient outcomes for future clinical studies.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Atherosclerosis
  • Stroke
  • Carotid Stenosis
  • Cerebral Infarction
  • Myocardial Infarction
  • Procedure: Carotid Endarterectomy (CEA)
    CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
  • Device: Carotid Artery Stenting (CAS)
    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.
    Other Name: Angioplasty of carotid artery and stent placement.
  • Active Comparator: Carotid Artery Endarterectomy (CEA)
    Intervention: Procedure: Carotid Endarterectomy (CEA)
  • Active Comparator: Carotid Artery Stenting (CAS)
    Intervention: Device: Carotid Artery Stenting (CAS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2502
December 2016
February 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 (CT angiogram) or MRA (magnetic resonance angiography) 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
0119970017, R01NS038384
Yes
University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Alabama at Birmingham
Principal Investigator: Thomas G. Brott, M.D. Mayo Clinic and University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
January 2013

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