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IMPROVE trial

Clinical impact of the use of IMPROVE for selection of patients for carotid revascularisation - Clinical impact of the use of IMPROVE for selection of patients for carotid revascularisation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58471
Enrollment
613
Registered
2025-07-03
Start date
2026-04-24
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carotid artery disease

Interventions

For patients that are randomised to the IMPROVE arm, the IMPROVE risk score will be provided as additional information for clinical decision-making on patient stratification for carotid revascularisat
Comparator: Patients randomised for the control arm (care-as-usual (CAU)) will be selected for revascularisation based on the guidelines for carotid interventions from the European Society for Vascula

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Recent (<30 days) stroke (modified Rankin scale =3) or TIAIpsilateral 30-99% NASCET carotid stenosis Life expectancy >5 years 

Exclusion criteria

Exclusion criteria: Possible cardiac source of embolismClotting disorderMRI contra-indications

Design outcomes

Primary

MeasureTime frame
Composite of ipsilateral ischemic stroke during 3-year follow-up and perioperative stroke and death.

Secondary

MeasureTime frame
Incidence of other cardiovascular ischemic symptoms (any stroke, myocardial infarction, TIA)Quality of life questionnaire (EQ-5D-5L) questionnaireFunctional outcome (mRS)Costs (iPCQ, iMCQ, iVICQ) questionnairesIncremental cost-effectiveness ratio (ICER; see economic analysis)Number of hospitalizations and carotid revascularisation procedures (CEA, CAS). 

Countries

Netherlands

Contacts

Public ContactM.E. Kooi

Universiteit Maastricht

eline.kooi@mumc.nl+31(0)43 – 387 4911

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026