Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

NCT06935383 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2503
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control. The targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care. Enrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months. If detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).

Conditions

STEMI (ST Elevation MI)

Outcome Measures

Primary Outcomes (1)

• Delta LVEF at post procedure and 6 months follow up visit

  Absolute difference in left ventricular ejection fraction (LVEF) measured within 24 hours post-primary percutaneous coronary intervention (PPCI) and 6 months follow up, using transthoracic echocardiography (TTE) assessed blind to treatment group assignment.

  From enrollment to the 6 months follow up visit

Study Arms (3)

Shame

SHAM COMPARATOR

Device: Diagnostic sequence

Treatment A

EXPERIMENTAL

Device: Therapeutic sequence; Device: Diagnostic sequence

Treatment B

EXPERIMENTAL

Device: Therapeutic sequence; Device: Diagnostic sequence

Interventions

Therapeutic sequence DEVICE

the required dose of treatment is administered through the CoFI system

Treatment A; Treatment B

Diagnostic sequence DEVICE

Diagnostic sequence to detect MVO

Shame; Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CLINICAL 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
• PPCI and Angiographic
• Culprit lesion in the LAD that is suitable for stenting
• COFI ballon can be placed according to IFU
• Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm

You may not qualify if:

• CLINICAL 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
• Known severe kidney disease (estimated glomerular filtration rate (eGFR) \< 30 ml/min) or on haemodialysis
• 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 100 mm Hg or an ongoing need for vasopressor support), and b. end-organ hypoperfusion with an arterial lactate level of 2.5 mmol/L or greater
• 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

Sponsors & Collaborators

• CorFlow Therapeutics AG: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Giovanni Luigi De Maria

  Oxford Heart Centre John Radcliffe Hospital Headley Way - OX3 9DU Oxford United Kingdom

  PRINCIPAL INVESTIGATOR

• Colin Berry

  The Royal Golden Jubilee Hospital, Glasgow, Uk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Catalano

CONTACT

+41 41 399 18 09; gcatalano@corflow.ch

Lennart Ivarsson

CONTACT

livarsson@corflow.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-03