CREST-2 Long-term Observational Extension Study (C2LOE)

Mayo Clinic

Status: Invitation-only

Conditions: Stenoses, Carotid

Treatments: Procedure: FDA-approved carotid stents; Procedure: Carotid Endarterectomy; Other: Intensive Medical Management

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05465122

1U01NS119169-01A1 (U.S. NIH Grant/Contract)

21-007363

Details and patient eligibility

About

The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.

Full description

Atherosclerotic plaque in the carotid arteries is responsible for 10 to 15% of all ischemic strokes. The ongoing NINDS-funded CREST-2 multicenter randomized clinical trial is testing whether in the short term (up to 4 years after study entry) procedural revascularization improves stroke prevention above and beyond what can be achieved with intensive medical management of vascular risk factors, especially hypertension and hyperlipidemia. Our proposal is for an observational extension of the CREST-2 clinical trial to test whether revascularization improves stroke prevention in the clinically relevant long term (up to 8 to 10 years). The current application proposes to use a site-less, centralized telephone approach to extend the follow-up of CREST-2 trial participants for assessing the primary study outcome (stroke) for up to 10 years. The average follow-up will increase from between 2-3 years (clinic-based randomized trial) to 7-8 years (observational extension). Each patient will be contacted by telephone at 6-month intervals, and queried regarding all hospitalizations since the last contact. Suspected stroke events will be adjudicated by an expert clinical events committee based on medical record review.

Enrollment: 2,480 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently active or graduated participants in the CREST-2 randomized trial
• Able to provide written informed consent by self
• Fluent in English or Spanish

Exclusion criteria

• Unable to provide written informed consent
• Inability to follow study procedures

Trial design

2,480 participants in 4 patient groups

Carotid Stenting Group (CAS)

Description:

Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)

Treatment:

Other: Intensive Medical Management

Procedure: FDA-approved carotid stents

Carotid Endarterectomy Group (CEA)

Description:

Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)

Treatment:

Other: Intensive Medical Management

Procedure: Carotid Endarterectomy

Intensive Medical Management Group - no CAS

Description:

Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217)

Treatment:

Other: Intensive Medical Management

Intensive Medical Management Group - no CEA

Description:

Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217)

Treatment:

Other: Intensive Medical Management