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RECRUITING
NCT07556887
NA

Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

613

Start Date

2026-03-31

Completion Date

2031-08-31

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

OTHER

IMPROVE 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.

Locations (10)

Rijnstate

Arnhem, Gelderland, Netherlands

Radboud UMC

Nijmegen, Gelderland, Netherlands

Zuyderland

Heerlen, Limburg, Netherlands

Maastricht University

Maastricht, Limburg, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Isala

Zwolle, Overijssel, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

Haaglanden MC

The Hague, South Holland, Netherlands

Utrecht UMC

Utrecht, Utrecht, Netherlands