Evaluation of Intracoronary Tirofiban and Adenosine via CoFI System for the Treatment of Microvascular Obstruction in Patients with ST-Elevation Myocardial Infarction
- Trial ID
- 2025-522060-32-00
- Protocol
- 2503
- Sponsor
- Corflow Therapeutics AG
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the CoFI system as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in subjects with ST-elevation myocardial infarction (STEMI) diagnosed with microvascular obstruction (MVO), and to identify markers of treatment efficacy compared to a control group. 5, 1, 3
Secondary objectives include:
- Evaluation of the safety of the investigational device, the diagnostic and therapeutic procedures, and the administered medicinal products at 30 days post-procedure. 4
- Assessment of changes in cardiac function using the regional wall motion score index (RWMSI) between early post-procedure and 6-month follow-up.
Participants
This clinical trial involves 70 participants diagnosed with ST-elevation myocardial infarction. The study population consists of both male and female patients within specific age ranges. Inclusion requires the presence of an infarct-related lesion in the proximal or mid left anterior descending artery, along with electrocardiogram evidence of acute anterior myocardial infarction. Selected individuals must exhibit symptoms consistent with myocardial ischemia within six hours of symptom onset. Participants must be suitable for primary percutaneous coronary intervention and meet specific angiographic criteria regarding the culprit lesion and the required dimensions for stenting. The investigation focuses on subjects presenting with microvascular obstruction.
Plans and Procedures
This phase 4, randomised study evaluates the efficacy of the CoFI system for the intracoronary infusion of adenosine and tirofiban to treat microvascular obstruction in patients with ST-elevation myocardial infarction. The research design utilizes a controlled methodology to assess the impact of these therapeutic agents compared to a control. The study procedures begin with a screening phase to ensure subjects meet specific angiographic and clinical criteria, such as an infarct-related lesion in the proximal or mid left anterior descending coronary artery and suitability for primary percutaneous coronary intervention. Following successful intervention, the primary endpoint involves measuring the absolute change in left ventricular ejection fraction via transthoracic echocardiography between 24 to 72 hours post-procedure and at a 6-month follow-up visit. Secondary endpoints include the evaluation of the regional wall motion score index and a composite safety assessment at 30 days. The overall duration of participant involvement extends to 6 months post-procedure, with assessments performed blinded to treatment assignment. Early termination may occur based on clinical safety parameters or deviations from the protocol.
Treatment
The experimental treatment involves the intracoronary administration of adenosine, provided as a 6 mg/2 ml solution for injection. The prescribed dosage is 300 µg.
The experimental treatment also includes tirofiban, administered as a 50 µg/ml solution for infusion. The dosage is 25 µg/kg via intracoronary use.
Efficacy
The primary efficacy endpoint is the absolute change in left ventricular ejection fraction (LVEF) from the period between 24 to 72 hours post-primary percutaneous coronary intervention (PPCI) to 6 months post-procedure. This parameter is measured using transthoracic echocardiography (TTE), and all assessments are conducted blinded to treatment group assignment.
Secondary efficacy parameters include the left ventricular regional wall motion score index (RWMSI) of the infarct zone at 6 months, corrected for the RWMSI recorded 24 to 72 hours post-PPCI, as assessed by 2D transthoracic echocardiography. Additionally, a composite safety endpoint is evaluated at 30 days, comprising device or procedure-related mortality, clinically driven target vessel/lesion revascularization, vessel dissection, and intrapulmonary thromboembolic events (IPTE), which includes the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization during the procedure.
Inclusion and Exclusion Criteria
Inclusion 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
Exclusion Criteria
- Unconscious on presentation
- Patients under judicial protection, legal guardianship or curatorship
- 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
- 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
- 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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Recruiting | 01 Dec 2025 | 70 |
 The Netherlands | Not Yet Recruiting | 01 Dec 2025 | — |
 Spain | Not Yet Recruiting | 01 Dec 2025 | 70 |
| Netherlands | — | — | 70 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Tirofiban Ibisqus 50 Mikrogramm/ml Infusionslösung | Test | INFUSIONSLÖSUNG | INTRACORONARY USE | 25 | 1 | PRD3005078 |
Adenosine 6 mg/2 ml solution for injection | Test | SOLUTION FOR INJECTION | INTRACORONARY USE | 300 | 1 | PRD9231676 |