Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Cardiac source of embolism

Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy.

MRI contra-indications

Pregnancy

Trial design

Treatments tested in this trial

  • IMPROVE Risk Model

Treatment groups

613 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maastricht University Medical Center

Lead sponsor

Academisch Ziekenhuis Maastricht

Collaborator

Amsterdam UMC

Collaborator

UMC Utrecht

Collaborator

Haaglanden Medical Centre

Collaborator

Isala

Collaborator

Radboud University Medical Center

Collaborator

Zuyderland Medical Centre

Collaborator

Albert Schweitzer Hospital

Collaborator

Rijnstate Hospital

Collaborator

Erasmus Medical Center

Collaborator