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Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Study acronym: IMPROVE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Secondary endpoints revised (9)
    • Site details revised at 10 of 10 sites
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07556887
Lead Sponsor Maastricht University Medical Center
Collaborators: Academisch Ziekenhuis Maastricht, Amsterdam UMC, UMC Utrecht, Haaglanden Medical Centre, Isala, Radboud University Medical Center, Zuyderland Medical Centre, Albert Schweitzer Hospital, Rijnstate Hospital, Erasmus Medical Center
Conditions
(from sponsor)
Carotid Artery Stenosis Symptomatic, Ischemic Cerebral Infarction, Stroke Ischemic, Atheroscleroses, Stroke (CVA) or TIA, Stroke, Intraplaque Hemorrhage, TIA (Transient Ischemic Attack) +2 more
Related terms Atherosclerosis, Carotid Artery Diseases, Carotid Stenosis, Ischemic Attack, Transient, Ischemic Stroke, Stroke
Enrollment 613 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov