RecruitingNot ApplicableNCT07556887

Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

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

Enrollment

613 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Stroke, Ischemic Stroke Stroke (CVA) or TIA TIA (Transient Ischemic Attack)Carotid Artery Stenosis Symptomatic Atheroscleroses Carotid Arteriosclerosis Ischemic Cerebral Infarction Intraplaque Hemorrhage Atherosclerosis Cerebral Infarction

Summary

Narrowing of the carotid artery due to atherosclerosis with an unstable plaque can cause a stroke. Patients with carotid artery disease who have had a TIA or minor stroke and are at high risk of another stroke are often treated with surgery or stenting to remove the plaque. For lower-risk patients, medication alone is the better option, as surgery also carries risks. A new decision method, based on MRI detection of unstable plaques (IMPROVE), can better assess stroke risk and help determine which patients do or do not need surgery. We are investigating whether this method is at least as effective as the standard approach, which mainly considers the degree of narrowing. We expect that this new method will help reduce strokes and lower healthcare costs. Patients will be followed for several years to compare which method is better for health and costs.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Mentally competent
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 Criteria4

Cardiac source of embolism
Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy.
MRI contra-indications
Pregnancy

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Interventions

OTHERIMPROVE Risk Model

All patients are screened in routine care for stenosis. The stroke risk is assessed using IMPROVE, incorporating plaque vulnerability (intraplaque haemorrhage (IPH) on MRI), stenosis degree, ischemic event type (ocular vs. cerebral), age and sex. The practitioner and patient discuss treatment options in shared decision making based on this risk score. Patients above the risk threshold (≥10% ipsilateral stroke risk within 3 years) receive a recommendation for revascularisation, those below an advice for OMT-only. The 10% threshold resulted in the largest stroke reduction in the decision analytic study. \~53% of the patients need an extra MRI. In \~47% an MRI is unnecessary since, based on the other risk factors, the stroke risk is already high or low and the MRI result does not affect the risk category.