Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
|Atherosclerosis Stroke Carotid Stenosis Cerebral Infarction Myocardial Infarction||Procedure: Carotid Endarterectomy (CEA) Device: Carotid Artery Stenting (CAS)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Prevention
|Official Title:||Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)|
- Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. [ Time Frame: 30 days and 4 years ]The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
- Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke). [ Time Frame: 4 years ]4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
|Study Start Date:||December 2000|
|Study Completion Date:||December 2016|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Carotid Artery Endarterectomy (CEA)
Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.
Procedure: Carotid Endarterectomy (CEA)
CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
Active Comparator: Carotid Artery Stenting (CAS)
Carotid artery stenting (CAS) is a procedure used to open narrowed carotid arteries. During the procedure, a small, expandable wire tube called a stent is permanently inserted into 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.
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 Rapid Exchange(RX) 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 case report forms(CRFs).
LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICES(CMS) ADMINISTRATIVE DATA
The purpose of linking Medicare-eligible CREST participants with CMS 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004732
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|Principal Investigator:||Thomas G. Brott, M.D.||Mayo Clinic and Rutgers University|