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REVITALISE Study
EU CTIS ID: 2025-522060-32-00
What this study is testing
The primary objective of the REVITALISE study is the evaluation of the CoFI system as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in STEACS (ST Elevation Acute Coronary Syndrome) subjects diagnosed with MVO (MicroVascular Obstruction) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects age ≥18 years old
- Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process
- Infarct-related lesion in proximal or mid left anterior descending coronary artery
- ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
- Symptoms onset to balloon time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 6 h
- Suitability for Primary PCI
You likely can't join if
- Unconscious on presentation
- Known coagulopathy
- Treatment with oral anticoagulation therapy
- Need for circulatory support or pre/intra-procedural ventilation
- Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min
- Heart failure with inotrope support and/or consideration for LVAD or heart transplant
See the full eligibility criteria
- Subjects age ≥18 years old
- Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process
- Infarct-related lesion in proximal or mid left anterior descending coronary artery
- ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
- Symptoms onset to balloon time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 6 h
- Suitability for Primary PCI
- Angiographic criterion - Culprit lesion in the LAD that is suitable for stenting
- Angiographic criterion - COFI balloon can be placed according to IFU
- Angiographic criterion - Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm
- Unconscious on presentation
- Known coagulopathy
- Treatment with oral anticoagulation therapy
- Need for circulatory support or pre/intra-procedural ventilation
- Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min
- Heart failure with inotrope support and/or consideration for LVAD or heart transplant
- Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the CIP, confound the data interpretation, or is associated with limited life expectancy of less than one year
- Current participation in another clinical study
- Known pregnancy or breast feeding
- CMRI substudy - Contraindication to CMRI a) Cardiac pacemaker or implantable defibrillator; b) Non-MRI compatible aneurysm clip; c) Neural Stimulator (i.e., TENS unit); d) Any implanted or magnetically activated device (insulin pump); e) Any type of non-MRI compatible ear implant; f) Metal shavings in the orbits; g) Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject; h) Any history indicating contraindication to MRI i) Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and j) Known hypersensitivity or contraindication to gadolinium contrast. k) Known severe kidney disease (e.g. estimated glomerular filtration rate (eGFR) < 30 ml/min) or on haemodialysis
- Angiographic criterion - Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification) preventing successful wiring with pressure wire
- Patients under judicial protection, legal guardianship or curatorship
- Angiographic criterion - Cardiac condition preventing the use of the CoFI System
- Angiographic criterion - Any pre or post stenting condition that the physician believes requires a pharmacological iv or ic drug administration to be adminstered before or during stenting, apart from standard of care administration of anaesthetics, heparin, nitrates or verapamil
- Mental disorder or language barrier that precludes informed assent/consent GCP, governing regulations and approved process
- Pericardial effusion (cardiac tamponade)
- Cardiogenic shock and/or persistence of cardiogenic shock at completion of primary PCI. Cardiogenic shock defined as a. hypotension (systolic blood pressure below 90 mm Hg or an ongoing need for vasopressor support), and b. end-organ hypoperfusion
- Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, ventricular septal defect, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or regurgitation, pericardial disease
- Major bleeding ≤ 30d prior to intervention defined according to BARC 3-5
- Major surgery ≤ 30d prior to intervention
- History of stroke, TIA or reversible ischemic neurological deficit within last 6 months
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.