Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation (NCT07556887) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation
Netherlands613 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called the IMPROVE tool to decide who gets carotid revascularization — can you explain what that tool looks at, and whether you think it would change the treatment path you're currently recommending for me?
2The trial is tracking stroke or death within 44 days of joining, as well as ipsilateral ischemic stroke over the longer follow-up — given my specific situation, how does my risk of those outcomes compare if I join the trial versus going straight to standard treatment?
3Since this trial is listed as Phase NA, which often means it's testing a decision-making strategy rather than a new drug or device, can you walk me through what being randomized would actually mean for my day-to-day care and how my treatment decisions would be made?
4My condition involves symptomatic carotid artery stenosis and a recent stroke or TIA, which means timing is critical — how quickly would I need to decide about this trial, and is there any risk that participating could delay a procedure I might need urgently?
5Are there standard-of-care options like carotid endarterectomy or stenting that I should consider first, and how does the evidence behind those compare to what this trial is still trying to find out?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: any strokes/deaths: from randomisation (day 1) until day 44. Ipsilateral ischemic strokes: from randomisation (day 1) through completion of follow-up (36 up to 60 months).