Carotid Procedures for Carotid Artery Stenosis
(C2LOE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term effectiveness of two procedures: carotid endarterectomy and carotid stenting. Both treatments aim to improve blood flow in the neck arteries, helping to prevent strokes. The trial compares these procedures with intensive medical care to determine which is most effective. It is ideal for individuals who participated in the previous CREST-2 study and can provide consent. Participants should speak English or Spanish. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to significant advancements in stroke prevention.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What is the safety track record for these treatments?
Research has shown that carotid endarterectomy (CEA) is generally safe, even for individuals with risk factors. One study found a 1.3% chance of stroke within 30 days for patients with one risk factor. For those with multiple risk factors, the stroke rate was slightly higher at 1.4%. However, early complications such as bruising, internal bleeding (hematoma), and brief strokes (transient ischemic attacks) can occur in about 8.7% of cases.
Studies have also examined carotid stenting (CAS). The risk of stroke or death within 30 days after this procedure is around 4.0%. Specifically, 1.2% of patients experienced death, while 3.0% had a stroke. Some patients also encountered issues like bleeding in the brain (intracranial hemorrhage) and blockage in the stent (in-stent occlusion).
Both treatments carry risks but are generally considered safe for stroke prevention. Discuss with a doctor to determine the best option.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments being evaluated in the CREST-2 Long-term Observational Extension Study because they offer potentially safer and more effective options for managing carotid artery disease. Carotid endarterectomy (CEA) is a surgical procedure that physically removes plaque from the artery, potentially reducing the risk of stroke with a well-established technique. Meanwhile, carotid stenting (CAS) involves inserting a small mesh tube to keep the artery open, which is less invasive and may offer quicker recovery times. Both treatments are being assessed alongside intensive medical management to see if they can provide better long-term outcomes compared to current standard medical therapies, which typically focus on medication and lifestyle changes alone.
What evidence suggests that this trial's treatments could be effective for carotid artery disease?
Research has shown that carotid endarterectomy (CEA), one of the treatments studied in this trial, can significantly lower the risk of stroke. One study found that people who underwent CEA were 3.1% less likely to have a stroke over five years compared to those who only received medication. Another study found that after CEA, the yearly risk of stroke was just 0.60%. Carotid stenting (CAS), another treatment option in this trial, has shown similar short-term results to CEA, such as the risk of stroke and death within 30 days. However, CAS requires experienced doctors because the procedure takes time to master. Overall, both CEA and CAS have effectively reduced stroke risk for patients with carotid artery problems. Participants in this trial will be assigned to different treatment arms to further evaluate these interventions.678910
Who Is on the Research Team?
James Meschia, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo carotid endarterectomy or carotid stenting as part of the CREST-2 trial
Follow-up
Participants are monitored for stroke prevention efficacy and safety after treatment
Long-term Observational Extension
Participants continue to be monitored for stroke prevention in the long term
What Are the Treatments Tested in This Trial?
Interventions
- Carotid Endarterectomy
- Carotid Stenting
- Intensive Medical Management
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Subjects assigned to the intensive medical management alone with no carotid endarterectomy (CEA) group in the CREST-2 study (NCT02089217)
Subjects assigned to the intensive medical management alone with no carotid stenting (CAS) group in the CREST-2 study (NCT02089217)
Subjects assigned to the intensive medical management with carotid stenting group in the CREST-2 study (NCT02089217)
Subjects assigned to the intensive medical management with carotid endarterectomy group in the CREST-2 study (NCT02089217)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
University of Alabama at Birmingham
Collaborator
Medical University of South Carolina
Collaborator
University of Maryland
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Citations
A comparative effectiveness study of carotid intervention for ...
For instance, in year 5, CEA is estimated to have decreased the risk of ipsilateral stroke by 3.1% (95% CI 1.9%–4.4%) compared to patients who received medical ...
Carotid Artery Disease: Then and Now | Stroke
After the periprocedural period, the annual risk of stroke was 0.64% for CAS and 0.60% for CEA. Pooled analysis also confirmed the negative ...
Carotid Endarterectomy vs Initial Medical Therapy in ...
The observed 5-year risk of fatal or nonfatal stroke among patients with carotid stenosis in the pragmatic sample was 7.5% (95% CI, 6.5%-8.7%) ...
A comparative effectiveness study of carotid intervention for ...
Objective: The results of current prospective trials comparing the effectiveness of carotid endarterectomy (CEA) vs standard medical therapy for long-term ...
Clinical and anatomic outcomes after carotid endarterectomy
Our data demonstrate favorable 30-day and long-term outcomes after CEA and confirm the long-term stroke prevention accorded by CEA. The 30-day combined stroke/ ...
Contemporary Outcomes Following Carotid ...
The current perioperative 30-day stroke/death rate after carotid endarterectomy in high physiologic risk patients with asymptomatic carotid stenosis is 4.7%.
Predicting Major Adverse Cardiovascular Events Following ...
Schermerhorn and colleagues showed that 30‐day major adverse cardiovascular events (MACE) occur in >7% of high‐risk patients undergoing CEA. To ...
Carotid endarterectomy remains safe in high-risk patients
Patients with a single risk factor had a stroke rate of 1.3% and those with multiple high-risk factors had a stroke rate of 1.4%. Take Home ...
Outcome of primary closure following carotid ...
Early complications (8.7%) included hematoma, transient ischemic attack, myocardial infarction, stroke, and death. Late complications involved myocardial ...
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cardiothoracicsurgery.biomedcentral.com
cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-024-02838-0Comparative on the effectiveness and safety of different ...
This study found that all three surgical methods are equally safe for the treatment of carotid artery stenosis and are effective in preventing stroke.
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