REVITALISE Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Corflow Therapeutics AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-03-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Corflow Therapeutics AG · Qmed Consulting A/S

External identifiers

EU CT number

2025-522060-32-00

ClinicalTrials.gov

NCT06935383

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis, Therapy

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.

Secondary objectives 2

1. Safety Objective: To evaluate the safety of the investigational device, the investigational procedure (diagnostic and therapeutic), and the medicinal products administered in the treatment arms, as assessed at 30 days post-procedure.
2. To evaluate the change in heart function using the regional wall motion score index (RWMSI), assessed between early post-procedure and 6-month follow-up.

Conditions and MedDRA coding

STEMI (ST elevated Myocardial Infarction)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Subjects age ≥18 years old
2. Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process
3. Infarct-related lesion in proximal or mid left anterior descending coronary artery
4. 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
5. 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
6. Suitability for Primary PCI
7. Angiographic criterion - Culprit lesion in the LAD that is suitable for stenting
8. Angiographic criterion - COFI balloon can be placed according to IFU
9. Angiographic criterion - Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm

Exclusion criteria 21

1. Unconscious on presentation
2. Patients under judicial protection, legal guardianship or curatorship
3. Mental disorder or language barrier that precludes informed assent/consent GCP, governing regulations and approved process
4. Pericardial effusion (cardiac tamponade)
5. 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
6. 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
7. Major bleeding ≤ 30d prior to intervention defined according to BARC 3-5
8. Major surgery ≤ 30d prior to intervention
9. History of stroke, TIA or reversible ischemic neurological deficit within last 6 months
10. Known coagulopathy
11. Treatment with oral anticoagulation therapy
12. Need for circulatory support or pre/intra-procedural ventilation
13. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min
14. Heart failure with inotrope support and/or consideration for LVAD or heart transplant
15. 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
16. Current participation in another clinical study
17. Known pregnancy or breast feeding
18. 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
19. Angiographic criterion - Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification) preventing successful wiring with pressure wire
20. Angiographic criterion - Cardiac condition preventing the use of the CoFI System
21. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The absolute change in left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography (TTE), between 24 to 72 hours post-primary percutaneous coronary intervention (PPCI) and 6 months post-procedure. All assessments will be performed blinded to treatment group assignment.

Secondary endpoints 2

1. Left ventricular regional wall motion score index (RWMSI) of the Infarct zone at 6 months, corrected for 24 to 72 hours post-PPCI RWMSI, assessed by 2D Transthoracic Echocardiography blinded to treatment group assignment.
2. Primary safety endpoint formally tested for statistical significance is the Composite of device or procedure-related mortality, clinically driven target vessel/lesion revascularization, vessel dissection and IPTE (defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization at any point during the CoFI procedure) assessed at 30 days.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Corflow Therapeutics AG

Sponsor organisation

Corflow Therapeutics AG

Address

Neuhofstrasse 3d

City

Baar

Postcode

6340

Country

Switzerland

Scientific contact point

Organisation

Corflow Therapeutics AG

Contact name

Giovanna Catalano

Public contact point

Organisation

Corflow Therapeutics AG

Contact name

Giovanna Catalano

Third parties 1

Locations

3 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications