ADENOSINE for ST-elevation myocardial infarction (STEMI)

Inclusion criteria

• {"criterion_text":"- Subjects age ≥18 years old\n- Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process\n- Infarct-related lesion in proximal or mid left anterior descending coronary artery\n- 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\n- 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\n- Suitability for Primary PCI\n- Angiographic criterion - Culprit lesion in the LAD that is suitable for stenting\n- Angiographic criterion - COFI balloon can be placed according to IFU\n- Angiographic criterion - Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in LVEF measured by transthoracic echocardiography (TTE) at 24–72 hours post-PPCI and at 6 months; assessments performed blinded to treatment group assignment."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"RWMSI assessed by 2D transthoracic echocardiography at 24–72 hours post-PPCI and at 6 months; corrected for early RWMSI; assessments blinded to treatment group."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite safety endpoint evaluated at 30 days using clinical and procedural assessments; includes device/procedure-related mortality, clinically driven target vessel/lesion revascularization, vessel dissection and IPTE (as defined)."}

France

Earliest CTIS Part Ii Submission Date

23-01-2026

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

42

Number Of Sites

6

Number Of Participants

70

Spain

Earliest CTIS Part Ii Submission Date

20-11-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

109

Number Of Sites

5

Number Of Participants

70

Netherlands

Earliest CTIS Part Ii Submission Date

04-02-2026

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

26

Number Of Sites

6

Number Of Participants

70

Primary sponsor

Full Name

Corflow Therapeutics AG

Organisation Type

Industry

Country Of Registered Address

Switzerland

Third parties

• {"country":"Denmark","full_name":"Qmed Consulting A/S","duties_or_roles":"CTIS admin","organisation_type":"Pharmaceutical company"}