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Procedure

Carotid Stenting vs. Endarterectomy for Carotid Stenosis (CREST-2 Trial)

N/A

Recruiting

Led By Thomas G. Brott, MD

Research Sponsored by Thomas G. Brott, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥35 years old

Life-long asymptomatic patients defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

CREST-2 Trial Summary

This trial will compare two methods of preventing stroke in patients with asymptomatic high-grade carotid stenosis. One group will have endarterectomy and the other will have carotid stenting with embolic protection.

Who is the study for?

This trial is for adults over 35 with asymptomatic high-grade carotid stenosis, who haven't had a stroke or TIA related to the stenosis in the last 180 days. They must be able to follow the study schedule and not be pregnant if of childbearing potential. Exclusions include recent major surgery, severe kidney disease, planned major surgeries, certain cancers, and intolerance to study medications.Check my eligibility

What is being tested?

The CREST-2 trial compares intensive medical management alone versus alongside either carotid endarterectomy (CEA) or carotid stenting (CAS) in preventing strokes. Participants are randomly assigned to one of these treatments and all receive uniform medical management directed by the study team.See study design

What are the potential side effects?

Potential side effects from CEA might include nerve injury leading to numbness or pain, bleeding, infection at incision site, heart attack or stroke during surgery. CAS could cause similar issues plus risks associated with placing a stent like blood vessel damage.

CREST-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 35 years old or older.

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I have never had a stroke or symptoms of a stroke.

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I have not had a stroke or mini-stroke on the same side as my narrowed artery in the last 6 months.

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My narrowed carotid artery can be treated with surgery or stenting.

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I am not able to have children or I have a negative pregnancy test.

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I am 35 years old or older.

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I am not able to have children or I have a negative pregnancy test.

CREST-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stroke and death

Secondary outcome measures

Cognitive Function

Effect modification

Major Stroke

CREST-2 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Intensive Medical Management - no CEAExperimental Treatment1 Intervention

Intensive Medical Management alone - no CEA

Group II: Intensive Medical Management - no CASExperimental Treatment1 Intervention

Intensive Medical Management alone - no CAS

Group III: Carotid Endarterectomy (CEA)Active Control1 Intervention

Carotid Endarterectomy

Group IV: Carotid Stenting (CAS)Active Control1 Intervention

Carotid Stenting

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

646,884 Total Patients Enrolled

4 Trials studying Carotid Stenosis

5,617 Patients Enrolled for Carotid Stenosis

Thomas G. Brott, M.D.Lead Sponsor

Thomas G. Brott, MD5.01 ReviewsPrincipal Investigator - Mayo Clinic

Mayo Clinic

Media Library

Carotid endarterectomy (CEA) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02089217 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this research benefits from a more diverse pool of subjects?

"This study is only for patients aged 35 to 100. In comparison, there are 21 similar trials for patients under 18 and 225 for patients over 65."

Answered by AI

To whom does this study's criteria apply?

"This study seeks 2480 participants with carotid ulcer who meet the following criteria: they must be between 35 and 100 years old, have no history of stroke or TIA in the 180 days leading up to the study, be asymptomatic, and have a modified Rankin Scale score of 0 or 1. Additionally, women of childbearing potential must take a negative pregnancy test prior to the study. Finally, applicants must be willing to comply with follow-up appointments and sign a consent form approved by the local IRB/MEC. Randomization will apply to only one carotid artery for patients with bilateral"

Answered by AI

In how many distinct sites is this research project being conducted?

"One hundred different medical sites are participating in this study. These locations are primarily situated in San Francisco, Takoma Park, and Manhasset. However, there are 100 other centres running this trial in various other cities. If you decide to participate in this study, try to enroll at the location nearest you to cut down on travel."

Answered by AI

Are we still enrolling subjects for this research project?

"The listed clinical trial on clinicaltrials.gov is looking for more patients as of 9/7/2022. This particular study was first posted on December 1st, 2014."

Answered by AI

How many people are the most that can be a part of this research project?

"The answer is affirmative. According to clinicaltrials.gov, this study is still recruiting patients. This research was originally shared on December 1st, 2014 and was most recently updated on September 7th, 2022. In total, the 2480 patients needed for this study will be recruited from 100 different sites."

Answered by AI