Clinical Impact of the Use of IMPROVE for Selection of Patients for Carotid Revascularisation: a Randomized Controlled Multicentre Non-inferiority Trial in Symptomatic Patients With 30-99% Carotid Stenosis
Sponsor: Maastricht University Medical Center
Trial Details
| Condition | Carotid Artery Stenosis Symptomatic, Ischemic Cerebral Infarction, Stroke Ischemic, Atheroscleroses, Stroke (CVA) or TIA, Stroke, Intraplaque Hemorrhage, TIA (Transient Ischemic Attack), Atherosclerosis Cerebral Infarction, Carotid Arteriosclerosis |
| Intervention | IMPROVE Risk Model |
| Phase | NA |
| Status | Recruiting |
| Participants | 613 |
| Est. Completion | 31 Aug 2028 |
| Last Updated | 15 May 2026 |
Primary Outcome
The primary outcome of the study is the composite of any stroke or death within 44 days after randomisation or ipsilateral ischemic stroke at any time during subsequent follow-up.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Mentally competent * 18 years or older * Recent (\<30 days) stroke (modified Rankin scale ≤3) or TIA * Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation assessed using non-invasive imaging according to NASCET criteria * Life expectancy \>5 years * Patient and stenosis are suitable for carotid revascularisation * Patient is agreeable to randomisation and willing to accept either IMPROVE-based or CAU-based selection method for carotid revascularisation Exclusion Criteria: * Cardiac source of embolism * Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy. * MRI contra-indications * Pregnancy
Trial Sites
Countries
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