Acute ischemic stroke is an important cause of death and disability. The management of acute ischemic stroke treatment has been improved after introduction of IV thrombolysis and mechanical thrombectomy (EVT) for proximal intracranial occlusions. Around 20% of patients with a proximal intracranial occlusion for which EVT is indicated, have a tandem lesion in the cervical internal carotid artery that may also need an interventional treatment. Huge variation in clinical practice exists and current guidelines suggest carotid endarterectomy (CEA) within two weeks after the initial event in order to prevent a recurrent stroke, however these recommendations are based on trials in a different population (subacute TIA, non-disabling stroke).
If a carotid stenosis is diagnosed, carotid artery stenting (CAS) can be performed during EVT. Immediate CAS may decrease the risk of recurrent stroke in the first two weeks and effectively treat the cause of stroke in a less invasive and more cost-effective way than CEA. A major concern in acute carotid artery stenting is the need for antiplatelet therapy to prevent in-stent thrombosis, potentially leading to an increase in hemorrhagic complications.
This multicenter randomized clinical trial will compare the efficacy and safety of two different treatment strategies in patients undergoing EVT with an ipsilateral tandem lesion (carotid artery stenosis of more than 50%): immediate carotid revascularization (CAS) during EVT versus deferred treatment within two weeks after initial event by carotid revascularization (CEA or CAS) according to the current guidelines and depending on the functional recovery of the patient. The trial wants to study the degree of disability 90 days after the initial stroke.
Hospitals specialised in EVT in Belgium and the Netherlands will carry out the study. A total of six hundred patients will participate in both countries.
| 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 |
| 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 |
