Immediate carotid artery stenting during endovascular treatment of acute ischemic stroke versus a deferred treatment of carotid artery stenosis. A randomized multicenter clinical trial in patients with acute ischemic stroke and carotid artery stenosis undergoing endovascular treatment.

Recruiting

• Conditions: Acute stroke; Carotid artery disease; 10007963; 10003216

• Registration Number: NL-OMON55982
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

- Acute ischemic stroke due to proximal intracranial occlusion in the anterior
circulation (intracranial ICA, A1, M1, proximal M2) on the CT angiography
- Stenosis >50% according to the NASCET criteria or initial occlusion of the
ipsilateral cervical carotid artery 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
- Baseline National Institute of Health Stroke Scale (NIHSS) score >= 2
- Age >18 years
- Written informed consent (deferred consent)

Exclusion Criteria

- Any intracranial hemorrhage
- Cervical carotid artery stenosis or occlusion with other causes than presumed
atherosclerosis (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
- Known allergy to aspirin and/or clopidogrel
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary effect parameter is the adjusted common odds ratio, estimated with<br /><br>ordinal logistic regression analysis, which represents a shift on the full<br /><br>distribution of the modified Rankin Scale score at 90 days. The analysis will<br /><br>be adjusted for known prognostic variables such as age, gender, stroke<br /><br>severity, collateral score and onset to randomisation time. Unadjusted and<br /><br>adjusted analyses will be reported with 95% confidence interval.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include mortality at 90 days, stroke severity 24 hours<br /><br>after EVT measured with the NIHSS score, recanalisation directly after EVT and<br /><br>24 hour after EVT, (symptomatic) intracranial hemorrhage and carotid<br /><br>(re-)occlusion.<br /><br><br /><br>Tertiary outcomes includes quality of life and cost-effectiveness measured with<br /><br>an Incremental cost-effectiveness ratio (ICER).</p><br>