Carotid artery stenting during endovascular treatment of acute ischemic stroke

Not Applicable

• Conditions: Acute ischemic stroke in patients with large vessel occlusion in the anterior circulation and a concommitant high grade ipsilateral carotid artery stenosis or occlusion of presumed atherosclerotic origin..; Circulatory System

• Registration Number: ISRCTN14956654
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-18
• Last Update Posted: 29 July 2024
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
2. Stenosis >50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography
3. 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)
4. Baseline National Institute of Health Stroke Scale (NIHSS) score =2
5. Age >18 years
6. Written informed consent (deferred consent)

Exclusion Criteria

1. Any intracranial hemorrhage
2. Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
3. Any exclusion criterion for EVT according to the guidelines
4. Pre stroke disability (defined as a modified Rankin Scale score >2)
5. Recent gastro-intestinal or urinary tract hemorrhage (<6 weeks)
6. Recent severe head trauma (<6 weeks)
7. Recent infarction on baseline brain CT in the same vascular territory (<6 weeks)
8. Known allergy to aspirin and/or clopidogrel
9. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset.The mRS score will be assessed by stroke research personnel by telephone interview, blinded for the treatment allocation

Secondary Outcome Measures

Name	Time	Method
1. NIHSS score at 24 hours and day 5-7, or at discharge (Medical examination)<br>2. Adequate recanalization after EVT (TICI 2b or higher) (Review of performed imaging)<br>3. Final infarct volume on brain CT at 24 hours (Review of performed imaging)<br>4. Arterial occlusive lesion (AOL) score on CTA at 24 hours (Review of performed imaging)<br>5. Any stroke within 90 days (Obtained from medical records)<br>6. Recurrent ipsilateral TIA/ischemic stroke within 90 days<br>7. Carotid artery re-occlusion at 24 hours and 90 days (Review of performed imaging)<br>8. Mortality at 90 days (Obtained from medical records)<br>9. Quality of life (EQ5D-5L) questionnaire at 90 days