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NCT Number: NCT05465122

CREST-2 Long-term Observational Extension Study

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.

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Key information

Conditions

Stenoses, Carotid Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carotid endarterectomy

Procedure

This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

FDA-approved carotid stents

Procedure

This is the standard proven therapy for carotid stenosis that involves an arteriotomy followed by removal of plaque and reconstruction of the vessel.

Intensive Medical Management

Other

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.

Primary outcomes

  1. Stroke

    Time frame: 5 years

    Number of participants to experience a stroke

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Medical University of South Carolina
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Alabama at Birmingham
  • University of Maryland

Registry information

Official study title

Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial

Acronym: C2LOE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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