Long-Term Observational Extension of Participants in CREST-2Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-Term Observational Extension of Participants in CREST-2

Conditions
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Stenoses, Carotid

Intervention / Treatment
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* Procedure: Carotid Endarterectomy
* Procedure: FDA-approved carotid stents
* Other: Intensive Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently active or graduated participants in the CREST-2 randomized trial at a site located in the United States Able to provide written informed consent by self Fluent in English Exclusion Criteria: Unable to provide written informed consent Inability to follow study procedures

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carotid Stenting Group (CAS)<br>Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217) | Procedure: FDA-approved carotid stents<br>* This is the standard proven therapy for carotid stenosis that involves an arterotomy followed by removal of plaque and reconstruction of the vessel.<br>Other: Intensive Medical Management<br>* INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.<br>|
| Carotid Endarterectomy Group (CEA)<br>Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217) | Procedure: Carotid Endarterectomy<br>* This is the standard proven therapy for carotid stenosis that involves an arterotomy followed by removal of plaque and reconstruction of the vessel.<br>Other: Intensive Medical Management<br>* INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.<br>|
| Intensive Medical Management Group - no CAS<br>Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217) | Other: Intensive Medical Management<br>* INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.<br>|
| Intensive Medical Management Group - no CEA<br>Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217) | Other: Intensive Medical Management<br>* INTERVENT risk factor management program to help manage patient's risk factors. The INTERVENT program will provide individualized risk factor counseling sessions (via telephone or internet) at regular interval by healthcare workers who are specially trained to help patients follow the medical management plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | Number of participants to experience a stroke | 5 years |