Carotid Stenting vs. Endarterectomy for Carotid Stenosis

(CREST-2 Trial)

Recruiting at 191 trial locations

Overseen By CREST-2 Administrative Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Antithrombotics

Disqualifiers: Stroke, Dementia, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

2486 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain anticoagulants like warfarin or have a history of intolerance to study medications, you may not be eligible to participate.

Is carotid stenting or endarterectomy safe for humans?

Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are generally considered safe, but the risk of complications can vary. Some studies suggest a higher risk of adverse events with CAS, especially in low-volume centers, while CEA is the standard treatment with known risks. Both procedures have been studied extensively, and understanding individual risk factors can help reduce the risk of stroke or death. ^{1 2 3 4 5}

How does the treatment for carotid stenosis differ from other treatments?

Carotid endarterectomy (CEA) is the standard treatment for carotid stenosis, especially for patients with significant blockage, while carotid artery stenting (CAS) is an alternative for those at high surgical risk or with challenging anatomy. CEA involves surgically removing plaque from the artery, whereas CAS uses a stent to keep the artery open, offering a less invasive option. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Carotid endarterectomy (CEA) and Carotid Stenting (CAS) for Carotid Stenosis?

Both Carotid endarterectomy (CEA) and Carotid Stenting (CAS) are effective in reducing the risk of stroke in patients with severe carotid stenosis, with CEA often considered the first-line treatment. CAS is a good alternative for patients who have a high surgical risk or challenging anatomy. ^{2 3 5 6 8}

Who Is on the Research Team?

George Howard, DrPH

Principal Investigator

University of Alabama at Birmingham

Lloyd Edwards, PhD

Principal Investigator

University of Alabama at Birmingham

Brajesh K. Lal, MD

Principal Investigator

University of Maryland

James F. Meschia, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 35 years old or older.

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

Patients must agree to comply with all protocol-specified follow-up appointments

Exclusion Criteria

I have a cancer diagnosis other than non-melanoma skin cancer.

I haven't had any major surgery or serious heart issues in the last month.

I have a heart condition that could cause blood clots.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either carotid endarterectomy, carotid stenting, or intensive medical management

4 years

Follow-up

Participants are monitored for stroke and cognitive function outcomes

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Carotid endarterectomy (CEA)
• Carotid Stenting (CAS)
• Intensive Medical Management - no CAS
• Intensive Medical Management - no CEA

Trial Overview 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.

How Is the Trial Designed?

Group I: Intensive Medical Management - no CEA Experimental Treatment 1 Intervention

Intensive Medical Management alone - no CEA

Group II: Intensive Medical Management - no CAS Experimental Treatment 1 Intervention

Intensive Medical Management alone - no CAS

Group III: Carotid Endarterectomy (CEA) Active Control 1 Intervention

Carotid Endarterectomy

Group IV: Carotid Stenting (CAS) Active Control 1 Intervention

Carotid Stenting

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Thomas G. Brott, M.D.

Lead Sponsor

Trials

1

Recruited

2,500+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study of 10,958 Medicare patients aged 66 and older, carotid artery stenting (CAS) showed similar in-hospital and 1-year stroke rates compared to carotid endarterectomy (CEA), indicating comparable efficacy in preventing strokes.

However, CAS patients experienced significantly higher all-cause mortality at 1 year (9.9% for CAS vs. 6.1% for CEA), which may be attributed to their higher baseline risk factors, such as existing coronary and peripheral arterial disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after carotid artery stenting and endarterectomy in the Medicare population. Wang, FW., Esterbrooks, D., Kuo, YF., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes after Carotid Endarterectomy and Carotid Artery Stenting for Carotid Stenosis in the ACS-NSQIP Database. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Trends and outcomes in Australian carotid artery revascularization surgery: 2010-2017. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Anatomic criteria determining high-risk carotid surgery patients. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes After Carotid Endarterectomy and Carotid Artery Stenting: A Propensity-Matched Cohort Analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

European Registry of Carotid Artery Stenting: results from a prospective registry of eight high volume EUROPEAN institutions. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Clinical and angiographic risk factors for stroke and death within 30 days after carotid endarterectomy and stent-protected angioplasty: a subanalysis of the SPACE study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes after carotid artery stenting and endarterectomy in the Medicare population. [2018]