Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trail (CREST 2)

ID Number 16-1887

Principal Investigator(s)
Stanley Tuhrim

Department(s) or Division(s)
Neurology

Description

CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy (CEA) plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenosis (CAS) plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors.

CREST-2 is seeking individuals who have narrowing of their carotid artery to participate in ongoing and future research studies for the prevention of stroke. 

Patients will be selected for either the CEA vs. intensive medical management trial or the CAS vs. intensive medical management trial based upon eligibility criteria for CEA or CAS. It is anticipated that most patients will be eligible for either trial. To approximate real-world practice, enrollment of such patients will follow referral patterns at a given center. Mechanisms will be in place to ensure enrollment of approximately 1240 patients in each of the trials. It is anticipated that approximately 2480 adult men and women with asymptomatic carotid stenosis will be enrolled.

This study is being conducted at Mount Sinai Hospital, Mount Sinai West, St. Luke's and Beth Israel (Mount Sinai East).

Recruitment Period
Approximately 5 years (anticipated, with a potential adaptive adjustment by the number of events at a point in follow-up developed in conjunction with NINDS and the DSMB, and described in the Statistical Analysis Plan (SAP)).

Length of Follow-Up
At least two years after last patient randomized.



Contact Information
Ricardo Renvill
(212) 241-2220
ricardo.renvill@mssm.edu

Recruiting Patients: Yes