Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial.
Louise Maes, Theodora Van Elk, Anne van der Meij...
https://pubmed.ncbi.nlm.nih.gov/39957001Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06511089
Carotid Artery Stenting During Endovascular Treatment of Acute Ischemic Stroke Comparing Immediate Versus Deferred Treatment of Cervical Carotid Artery Stenosis
Led by University Medical Center Groningen · Updated on 2024-07-19
600
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of immediate carotid artery stenting (CAS) during endovascular thrombectomy (EVT) in patients who have an acute ischemic stroke caused by a large vessel blockage in the brain and a high-grade narrowing or blockage of the carotid artery. This study compares immediate CAS during EVT with deferred treatment or medical management alone. It aims to determine if placing a stent right away improves blood flow and reduces the risk of another stroke, while monitoring for possible complications like bleeding. The study randomly assigns patients to two groups. One group receives CAS during EVT, with the stent placed either just before or directly after removing the brain clot. The other group follows current guidelines: they may have carotid surgery or stenting later if they have a less severe stroke, or receive medical management alone if the stroke is severe. This design helps compare immediate stenting versus deferred or no stenting approaches. Participants will be assessed through several measures including the modified Rankin Scale at 90 days to evaluate disability, NIH Stroke Scale scores at 24 hours, brain imaging to check blood flow and infarct size, and monitoring for stroke recurrence or artery re-occlusion. Quality of life and survival will also be followed for three months. The total study duration is from November 2022 to November 2026, with blinded evaluation of outcomes to ensure unbiased results.
CONDITIONS
Brief Title
Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Acute ischemic stroke caused by a blockage in a major artery of the brain's anterior circulation
- Ipsilateral cervical carotid artery narrowing greater than 50% or blockage of presumed atherosclerotic origin
- Eligible for endovascular thrombectomy within 6 hours or up to 24 hours after stroke onset based on imaging
- Stroke severity score (NIHSS) of 2 or higher
- Able to provide written informed consent (deferred consent allowed)
You will not qualify if you...
- Any brain bleeding or intracranial hemorrhage
- Narrowing or blockage of the carotid artery caused by conditions other than atherosclerosis, such as dissection or carotid web
- Any exclusion criteria for endovascular thrombectomy according to guidelines
- Pre-stroke disability with modified Rankin Scale score greater than 2
- Recent severe bleeding in gastrointestinal or urinary tract within 6 weeks
- Recent severe head injury within 6 weeks
- Recent stroke in the same brain area within 6 weeks
- Known allergy to aspirin or clopidogrel
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Treatment occurs during the endovascular thrombectomy procedure and immediate post-procedure period.
Participants receive either immediate carotid artery stenting during endovascular thrombectomy or deferred treatment according to national guidelines.
1 procedure visit (in-person)
Follow-up
Duration - Up to 90 days
Participants are monitored for recovery, stroke recurrence, and overall health outcomes for up to 90 days after treatment.
Approximately 3 visits over 90 days
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
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Research Team
M
Maarten Uyttenboogaart, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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