Randomised EValuation of Therapies for microvAscuLar Injury in STEACS (REVITALISE)

CorFlow Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: STEMI (ST Elevation MI)

Treatments: Device: Therapeutic sequence; Device: Diagnostic sequence

Study type: Interventional

Funder types: Industry

Identifiers

NCT06935383

2503

Details and patient eligibility

About

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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

CLINICAL criteria

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

   PPCI and Angiographic

7. Culprit lesion in the LAD that is suitable for stenting

8. COFI ballon can be placed according to IFU

9. Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm

Exclusion criteria

CLINICAL criteria

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. Known severe kidney disease (estimated glomerular filtration rate (eGFR) < 30 ml/min) or on haemodialysis

5. Pericardial effusion (cardiac tamponade)

6. 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

7. 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

8. Major bleeding ≤ 30d prior to intervention defined according to BARC 3-5

9. Major surgery ≤ 30d prior to intervention

10. History of stroke, TIA or reversible ischemic neurological deficit within last 6 months

11. Known coagulopathy

12. Treatment with oral anticoagulation therapy

13. Need for circulatory support or pre/intra-procedural ventilation

14. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min

15. Heart failure with inotrope support and/or consideration for LVAD or heart transplant

16. 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

17. Current participation in another clinical study

18. Known Pregnancy or breast feeding

    If CMRI substudy to be confirmed at the time of consent to the substudy:

19. Contraindication to CMRI

    1. Cardiac pacemaker or implantable defibrillator;
    2. Non-MRI compatible aneurysm clip;
    3. Neural Stimulator (i.e., TENS unit);
    4. Any implanted or magnetically activated device (insulin pump);
    5. Any type of non-MRI compatible ear implant;
    6. Metal shavings in the orbits;
    7. Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
    8. Any history indicating contraindication to MRI
    9. Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
    10. Known hypersensitivity or contraindication to gadolinium contrast.

PPCI and Angiographic criteria 19. Functional coronary collateral supply (Rentrop grade 2/3) to the infarct-related artery 20. Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification) preventing successful wiring with pressure wire 21. Cardiac condition preventing the use of the CoFI System 22. Any pre or post stenting condition that the physician believes requires a pharmacological iv or ic drug administration for a cardiac related condition to be administered before or during stenting, apart from standard of care administration of anaesthetics, heparin, nitrates or verapamil

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 3 patient groups

Shame

Sham Comparator group

Treatment:

Device: Diagnostic sequence

Treatment A

Experimental group

Treatment:

Device: Diagnostic sequence

Device: Therapeutic sequence

Treatment B

Experimental group

Treatment:

Device: Diagnostic sequence

Device: Therapeutic sequence