Revascularization for Carotid Artery Stenosis
(CREST-H Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether improving blood flow in the carotid arteries (major blood vessels in the neck) can reverse cognitive issues, such as memory problems, in individuals with narrowed arteries who have not shown stroke symptoms. It builds on an existing study that examines two treatment options: intensive medical care alone or combined with a procedure to open the artery (Carotid Artery Stenting or Carotid Endarterectomy). The trial specifically seeks participants already involved in the larger study who exhibit signs of blood flow issues and cognitive problems. Participants in the CREST-2 trial who have noticed memory difficulties may find this relevant. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both carotid artery stenting and carotid endarterectomy are generally safe for treating carotid artery stenosis, a condition where the neck arteries narrow. Studies have found that complications from carotid artery stenting are rare. For instance, one study reported that only 1.4% of patients experienced hyperperfusion syndrome, where excessive blood flows to the brain, and just 0.4% had any brain bleeding. This suggests that most patients tolerate the procedure well.
Carotid endarterectomy is also considered relatively safe. In patients with higher risk factors, the chance of having a stroke after the procedure ranged from 1.3% to 1.4%. Another study with many participants found a slightly higher stroke risk of about 2%, but overall, the procedure remains safe, even for those at higher risk.
These findings suggest that both treatments are generally safe and well-tolerated by patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the CREST-H trial because it explores different approaches to managing asymptomatic carotid stenosis, a condition that can lead to strokes. The trial compares intensive medical management, which includes medications like high-dose cholesterol-lowering agents and blood pressure control, with surgical options such as Carotid Artery Stenting (CAS) or Carotid Endarterectomy (CEA). Unlike the standard care that typically involves either surgery or medications alone, this trial examines whether combining these strategies can improve outcomes. By studying these approaches, researchers hope to determine the most effective way to prevent strokes in patients who show no symptoms but have significant narrowing in their carotid arteries.
What evidence suggests that this trial's treatments could be effective for cognitive impairment in patients with high-grade asymptomatic carotid artery stenosis?
Research has shown that carotid artery stenting (CAS), one of the treatments in this trial, safely and effectively treats narrowing in the carotid arteries. Studies indicate that CAS provides good long-term results and can help prevent strokes in individuals with this condition. Carotid endarterectomy (CEA), another treatment option in this trial, offers a slight advantage in reducing stroke risk compared to medication alone. This benefit begins in the second year after treatment and continues over time. Both procedures aim to improve blood flow, which might help with memory and thinking problems if these issues stem from poor blood flow. These findings suggest that treating narrowed carotid arteries might not only lower stroke risk but also help with cognitive issues related to blood flow.12678
Who Is on the Research Team?
E Sander Connolly, MD
Principal Investigator
Columbia University
David S Liebeskind, MD
Principal Investigator
University of California, Los Angeles
Randolph S Marshall, MD
Principal Investigator
Columbia University
Ronald M Lazar, PhD
Principal Investigator
University of Alabama at Birmingham
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
Baseline Assessment
Baseline cognitive assessments and imaging (MRI or CT) are performed for all participants
Treatment
Participants receive either intensive medical management alone or in combination with carotid revascularization (CEA or CAS)
Follow-up
Participants are monitored for cognitive changes and imaging outcomes at 1 year and annually up to 4 years
What Are the Treatments Tested in This Trial?
Interventions
- Carotid Artery Stenting
- Carotid Endarterectomy
- Intensive Medical Management
How Is the Trial Designed?
2
Treatment groups
Active Control
These patients will have been randomized (via the parent trial, CREST-2) to receive medical management only, which includes aspirin. high dose cholesterol lowering agent to a target LDL\<70, intensive blood pressure management to target \<130/80, smoking cessation, and diabetic control.
These patients will have been randomized (via the parent trial, CREST-2) to receive intensive medical management as well as either Carotid Endarterectomy (CEA--if they are in the parent study Surgical trial) or Carotid Artery Stenting (CAS--if they are in the parent study Stenting trial).
Carotid Artery Stenting is already approved in European Union, United States, Canada for the following indications:
- Symptomatic carotid stenosis ≥70%
- Asymptomatic carotid stenosis >60%
- Symptomatic carotid stenosis 50-69%
- Symptomatic carotid stenosis ≥70%
- Asymptomatic carotid stenosis >60%
- Symptomatic carotid stenosis 50-69%
- Symptomatic carotid stenosis ≥70%
- Asymptomatic carotid stenosis >60%
- Symptomatic carotid stenosis 50-69%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
University of California, Los Angeles
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Mayo Clinic
Collaborator
University of Alabama at Birmingham
Collaborator
University of Maryland
Collaborator
Citations
Long-term outcomes of carotid artery stenting in patients ...
CAS is a safe and effective procedure for carotid artery stenosis. Although the incidence of complications is low, fatal complication such as hyperperfusion- ...
Carotid Artery Stenting Outcomes by Neurointerventional ...
Secondary outcomes included mortality not captured above, asymptomatic ICH, transient ischemic attack, successfully treated distal embolization, ...
Real-World Outcomes of Carotid Artery Stenting in ...
The purpose of this study was to investigate the real-world clinical outcomes of CAS in symptomatic and asymptomatic patients with carotid artery stenosis.
4.
eurointervention.pcronline.com
eurointervention.pcronline.com/article/thirty-day-outcomes-of-carotid-endarterectomy-versus-carotid-artery-stenting-in-asymptomatic-and-symptomatic-patients-a-propensity-score-matched-analysisThirty-day outcomes of carotid endarterectomy versus ...
This study aims to compare the 30-day outcomes of stroke, transient ischaemic attack (TIA), acute myocardial infarction (AMI) and death with propensity-matched ...
Long-Term Results of Stenting versus Endarterectomy for ...
We found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, ...
Functional and Safety Outcomes of Carotid Artery Stenting ...
This cross-sectional study evaluates the clinical and technical outcomes of carotid artery stenting vs no stenting during mechanical ...
Real-World Outcomes of Carotid Artery Stenting in ...
Our results showed a relatively lower incidence of hyperperfusion syndrome (1.4%) and any ICH (0.4%) than that in a previous study. This result ...
Carotid Artery Stenting: JACC State-of-the-Art Review
The improvement in carotid endarterectomy outcomes over the past 50 years (A), is comparable to the improvement in carotid stenting outcomes (B) over the last ...
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