Status:
RECRUITING
Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Stroke, Acute
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Background and study aims A stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off. Approximately 1 in 5 patients suffering stroke ha...
Eligibility Criteria
Inclusion
- Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
- Stenosis \>50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography
- Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging selection (conform current guidelines)
- Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2
- Age \>18 years
- Written informed consent (deferred consent)
Exclusion
- Any intracranial hemorrhage
- Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
- Any exclusion criterion for EVT according to the guidelines
- Pre stroke disability (defined as a modified Rankin Scale score \>2)
- Recent gastro-intestinal or urinary tract hemorrhage (\<6 weeks)
- Recent severe head trauma (\<6 weeks)
- Recent infarction on baseline brain CT in the same vascular territory (\<6 weeks)
- Known allergy to aspirin and/or clopidogrel
- Pregnancy
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06511089
Start Date
November 15 2022
End Date
November 15 2026
Last Update
July 19 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ