Carotid artery stenting during treatment of acute stroke
Carotid Artery Stenting During Endovascular Treatment of Acute Ischemic Stroke: A Randomized Multicenter Clinical Trial in Patients With Acute Ischemic Stroke and Carotid Artery Stenosis Undergoing Endovascular Treatment
This study is testing if adding carotid artery stenting during a stroke treatment can help improve blood flow to the brain and lower the chances of having another stroke for patients with blocked carotid arteries.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06511089 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of immediate carotid artery stenting (CAS) during endovascular thrombectomy (EVT) for patients suffering from acute ischemic stroke due to large vessel occlusion. The study aims to determine whether performing CAS can improve cerebral blood flow and reduce the risk of recurrent strokes compared to standard treatment. Participants will be randomly assigned to receive either CAS or usual care during their EVT procedure. The trial focuses on patients with significant carotid artery stenosis or occlusion, assessing both the potential benefits and risks associated with the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with acute ischemic stroke and significant carotid artery stenosis or occlusion who are eligible for EVT.
Not a fit: Patients with intracranial hemorrhage or those with carotid artery issues not related to atherosclerosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery outcomes for stroke patients by improving blood flow to the brain.
How similar studies have performed: While the approach of combining CAS with EVT is being explored, this specific methodology is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Maarten Uyttenboogaart, MD PhD — University Medical Center Groningen
- Study coordinator: Maarten Uyttenboogaart, MD PhD
- Email: m.uyttenboogaart@umcg.nl
- Phone: +31 50 3612400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.