Using IMPROVE to guide carotid revascularisation decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares an IMPROVE-based patient selection method against usual care for carotid revascularisation in symptomatic carotid stenosis. Eligible adults with recent stroke or TIA and 30–99% ipsilateral stenosis will be randomized to treatment selection by IMPROVE risk scoring or by conventional criteria, with follow-up over several years to assess health outcomes and costs. The IMPROVE model combines MRI plaque vulnerability (intraplaque haemorrhage) with clinical risk factors to predict stroke risk and guide whether revascularisation is beneficial. The study aims to determine if IMPROVE-based selection reduces recurrent stroke or other vascular events and lowers overall costs compared with standard selection. Primary outcomes include stroke recurrence and health-economic impact, with safety and feasibility as secondary considerations.

Why it matters

Who can join: the full rules

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

Where it's running

• Maastricht University
  Maastricht, Limburg, Netherlands Recruiting
• Rijnstate
  Arnhem, Gelderland, Netherlands Not yet recruiting
• Radboud UMC
  Nijmegen, Gelderland, Netherlands Not yet recruiting
• Zuyderland
  Heerlen, Limburg, Netherlands Not yet recruiting
• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Not yet recruiting
• Isala
  Zwolle, Overijssel, Netherlands Not yet recruiting

Study contacts

• Principal investigator: M. Eline Kooi, Prof. dr. — Maastricht University
• Study coordinator: M. Eline Kooi, Prof. dr.
• Email: improve.trial@mumc.nl
• Phone: +31 43 387 4911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.