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NCT07556887Recruiting

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

Source: ClinicalTrials.gov · Last updated 15 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
613 (estimated)
First submitted
18 Feb 2026
Start date
31 Mar 2026
Primary completion date
31 Aug 2028
Lead sponsor
Maastricht University Medical Center
Diseases
Stroke
NCT number
NCT07556887

What you commit to

  • Study type: Interventional
  • Planned participants: 613
  • From 31 Mar 2026 to the primary completion date, 31 Aug 2028
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • MRI contra-indications
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC
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AmsterdamNetherlandsNot yet recruiting
Rijnstate
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ArnhemNetherlandsNot yet recruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsNot yet recruiting
Zuyderland
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HeerlenNetherlandsNot yet recruiting
Maastricht University
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MaastrichtNetherlandsRecruiting
Radboud UMC
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NijmegenNetherlandsNot yet recruiting
Erasmus MC
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RotterdamNetherlandsNot yet recruiting
Haaglanden MC
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The HagueNetherlandsNot yet recruiting
Utrecht UMC
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UtrechtNetherlandsNot yet recruiting
Isala
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ZwolleNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.