NCT06511089 Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
| NCT ID | NCT06511089 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Medical Center Groningen |
| Condition | Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2026-04-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2022-11-15 with a primary completion date of 2026-04-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Maarten Uyttenboogaart, MD PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06511089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06511089 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT06511089 currently recruiting?
Yes, NCT06511089 is actively recruiting participants. Contact the research team at m.uyttenboogaart@umcg.nl for enrollment information.
Where is the NCT06511089 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06511089 clinical trial?
NCT06511089 is sponsored by University Medical Center Groningen. The principal investigator is Maarten Uyttenboogaart, MD PhD at University Medical Center Groningen. The trial plans to enroll 600 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.