Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke versus deferred treatment of carotid artery stenosis |
| Participants (P) | Patients with acute ischemic stroke with a CT-angiography proven intracranial large vessel occlusion in the anterior circulation (ICA, A1, M1 or M2) as well as an ipsilateral cervical carotid artery tandem lesion of presumed atherosclerotic origin with a stenosis >50% or an ipsilateral acute proximal internal carotid artery occlusion who are treated with endovascular thrombectomy (EVT) according to the guidelines |
| Intervention (I) | The cervical carotid artery lesion will be treated with a stent during the EVT (just before or directly after intracranial thrombus removal) |
| Control (C) | The control group will be treated according to the national guidelines with carotid endarterectomy of carotid artery stenting (for patients with non-disabling stroke) or medical management alone (for patients with severe disabling stroke). |
| Outcome (O) | Modified Rankin Scale (mRS) score at 3 months after stroke onset |
| Trial Design | A randomized, controlled, open-label, multicentre trial |
| Sample Size | 600 participants randomised |
| Trial duration | 45 months from FPI to CSR |
| Budget | 2 302 541,43 €of which 1 455 072,05 € in The Netherlands and 847 469,38 € in Belgium |
Trial team
| Sponsor | UMC Groningen,The Netherlands |
| Chief Investigator | Prof Dr M Uyttenboogaart |
| BCC | Universitaire Ziekenhuizen Leuven, Belgium |
| National Coordinator | Prof Dr R Lemmens |
| Belgian sites | AZ Groeninge, AZ St Jan Brugge, CHC MontLégia, CHU Charleroi, Clinique Universitaires St Luc Bruxelles, Hôpital Erasme, UZ Gent, UZ Leuven, UZ Antwerpen, ZOL |
| Number of participating sites | Netherlands 12 sites and Belgium 10 sites |
DOCUMENTS
References
Funding scheme
