Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)

Overview
The purpose of the CREST study 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.

Purpose
The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid angioplasty with stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Patients will be followed for up to four years. CAS is a relatively new procedure that has increased in popularity in recent years due in part to advances in stent technology. Stents are medical devices approved and commonly used for treatment of heart disease. The investigational stent that will be used in this trial is the ACCULINK Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.

The ACCUNET Embolic Protection System (an umbrella-like device that expands above the narrowed portion of the carotid artery) will be used in conjunction with the ACCULINK stent. The 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 ACCUNET System is closed and removed after the stent is placed.

Many interventionalists believe that CAS has advantages over CEA because CAS is less invasive. 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. A balloon dilates the artery and the stent is then placed to cover the plaque and hold the artery open. Even though both procedures provide benefits to patients, no studies have shown conclusively which procedure, stenting or surgery, is better overall. Patients 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.

Eligibility

Inclusion criteria

    • Patient must be 18 years or age or older
    • Symptomatic patients with recent neurological events (TIA or non-disabling stroke)
    • Patients with carotid stenosis greater than 50% by angiography or 70% by ultrasound are eligible for randomization
    • Lesion in ICA with or without common carotid artery involvement
    • ICA reference diameter > 4.0 mm and < 90 mm
    • Candidate for CEA

Exclusion criteria

    • Evolving stroke
    • Allergy/intolerance to ASA, ticlopidine, clopidogrel
    • Active bleeding, coagulopathy or refusal of blood transfusions
    • History of major ipsilateral stroke
    • Severe dementia
    • ICH in past 12 months
    • Recent (<7 days) stroke of sufficient size to be at risk of hemorrhagic conversion
    • Hemorrhagic transformation of an ischemic stroke within the past 60 days
    • Hgb <10 g/dl, platelet count <125,000/ul, uncorrected INR >1.5, bleeding time > 1 min. beyond upper limit, or heparin-associated thrombocytopenia
    • Condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe
    • Neurologic illnesses within past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke
    • Actively participating in another drug or device study
    • Vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery
    • Knowledge of cardiac sources of emboli
    • MI within previous 30 days
    • Recent GI bleed
    • Non-surgical or a high risk surgical candidate

Study design
This is a Phase III randomized, multicenter treatment study.

Location & contact
Andrew Ringer, MD (Principal investigator)
University of Cincinnati Medical Center
222 Piedmont Avenue, #3100
Cincinnati, OH 45219
Telephone: 513-558-5398
Fax: 513-558-7702
Email: suzanne.kempisty-cliver@uc.edu 

More information
More info is available for this study.
CREST website
Start date: 6/2004
Close date: upon enrollment of 60-65 patients.
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Study ID number: R01NS3838

 


Copyright © University of Cincinnati, 2004