REVITALISE STUDY
Research type
Research Study
Full title
Randomised EValuation of Therapies for microvAscuLar Injury in STEACS – REVITALISE Study
IRAS ID
1011912
Contact name
Giovanna Catalano
Contact email
Sponsor organisation
Corflow Therapeutics AG
Clinicaltrials.gov Identifier
Research summary
Adaptive platform design, randomised, multi-arm, international, multi site, open-label comparative clinical investigation designed to allow for administration of drugs that may potentially treat microvascular injury in patients with heart attack (ST elevated) undergoing treatment by coronary angioplasty and stenting. The CoFI system (device under investigation) allows the diagnosis of microvascular obstruction (poor blood flow in the heart muscle). The study is based on a master protocol already including two therapeutic arms. As the trial progresses, additional experimental arms may be introduced, and any addition of subsequent therapeutic arms will be submitted as an appendix to the protocol to the participating countries. Participants would one treatment in the catheterisation lab and would then be followed up for 12 months post procedure. The heart function would be assessed immediately after procedure, 3 months and 6 months after procedure using Echocardiography (ultrasound imaging of the heart).
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0109
Date of REC Opinion
29 Oct 2025
REC opinion
Further Information Favourable Opinion