Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Recruiting now · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07556887

Run by

Maastricht University Medical Center

People needed

613

Starts

2026-03-31

Expected to finish

2031-08-31

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Maastricht University — Maastricht, Limburg, Netherlands (enrolling)
• Radboud UMC — Nijmegen, Gelderland, Netherlands
• Zuyderland — Heerlen, 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
• Rijnstate — Arnhem, Gelderland, Netherlands
• Utrecht UMC — Utrecht, Utrecht, Netherlands

Full record on ClinicalTrials.gov

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