Actively Recruiting
Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
Led by University Medical Center Groningen · Updated on 2024-07-19
600
Participants Needed
1
Research Sites
208 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
Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only. Objective: to assess the safety and efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis \>50% or occlusion of the ipsilateral cervical carotid artery. Study design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS/CEA or medical management alone). Outcome assessment will be blinded for treatment allocation.
CONDITIONS
Official Title
Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute ischemic stroke caused by a blockage in a large brain artery in the anterior circulation (intracranial ICA, M1, proximal M2) confirmed by CT angiography
- Ipsilateral cervical carotid artery stenosis greater than 50% or occlusion of presumed atherosclerotic origin on baseline CT angiography
- Eligible for endovascular thrombectomy within 6 hours of stroke onset or within 6 to 24 hours based on perfusion CT imaging
- National Institute of Health Stroke Scale (NIHSS) score of 2 or higher at baseline
- Age over 18 years
- Written informed consent (deferred consent allowed)
You will not qualify if you...
- Any intracranial hemorrhage
- Cervical carotid artery stenosis or occlusion caused by reasons other than presumed atherosclerosis (e.g., carotid artery dissection, floating thrombus, carotid web)
- Any exclusion criteria for endovascular thrombectomy according to current guidelines
- Pre-stroke disability with a modified Rankin Scale score greater than 2
- Recent gastrointestinal or urinary tract bleeding within 6 weeks
- Recent severe head trauma within 6 weeks
- Recent infarction in the same brain vascular territory on baseline CT within 6 weeks
- Known allergy to aspirin and/or clopidogrel
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
M
Maarten Uyttenboogaart, MD PhD
CONTACT
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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