Carotid Revascularization Endarterectomy Versus Stenting Trial "CREST"

Active, not recruiting

Phase 3 Results

Trial Description

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).

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 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.

Conditions

Interventions

  • Endarterectomy, carotid (CEA)Procedure/Surgery
    Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
  • Stent, carotid Procedure/Surgery
    Intervention Desc: Intravascular procedure to maintain carotid artery patency
  • Carotid Endarterectomy (CEA) Procedure
    Intervention Desc: CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
    ARM 1: Kind: Experimental
    Label: Carotid Artery Endarterectomy (CEA)
  • Carotid Artery Stenting (CAS) Device
    Other Names: Angioplasty of carotid artery and stent placement.
    Intervention Desc: 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 1: Kind: Experimental
    Label: Carotid Artery Stenting (CAS)

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Eligible patients will be randomized to undergo either CAS or CEA. All will receive aspirin antiplatelet therapy, treatment for hypertension, and management of other stroke risk factors. Follow-up will last four years, including clinic visits at 1, 6, 12, 18, 24, 30, 36, 42, and 48 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Mortality, stroke, or myocardial infarction at 30 days postoperatively; ipsilateral stroke at 30 days post-operatively.
Primary 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. 4 years Yes
Secondary To describe differential efficacy of CAS and CEA in male and female participants. 4 years Yes
Secondary To evaluate differences in measures of health related quality of life and cost effectiveness. 1-year No
Primary Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke 4 years Yes
Secondary 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). 4 years Yes

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