AzTrials
AzTrials

STEMI (ST Elevation MI)Phase 2REVITALISENCT06935383

Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

A Phase 2 study testing Therapeutic sequence and Diagnostic sequence in people with STEMI (ST Elevation MI), run by CorFlow Therapeutics AG.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
STEMI (ST Elevation MI)
What is being tested?
Therapeutic sequence and Diagnostic sequence
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
No sites listed yet
Study dates
Sep 2025to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)
Show all 32Show fewer
  • 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
  • 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
  • If CMRI substudy to be confirmed at the time of consent to the substudy:
  • Contraindication to CMRI
  • Cardiac pacemaker or implantable defibrillator;
  • Non-MRI compatible aneurysm clip;
  • Neural Stimulator (i.e., TENS unit);
  • Any implanted or magnetically activated device (insulin pump);
  • Any type of non-MRI compatible ear implant;
  • Metal shavings in the orbits;
  • Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
  • Any history indicating contraindication to MRI
  • Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Giovanna Catalano contact

+41 41 399 18 09

gcatalano@corflow.ch

Lennart Ivarsson contact

livarsson@corflow.ch

About this study

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.

Read more

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).

Being tested
Therapeutic sequence, Diagnostic sequence
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic sequenceDevice

    the required dose of treatment is administered through the CoFI system

  • Diagnostic sequenceDevice

    Diagnostic sequence to detect MVO

Study groups in NCT06935383
Study groupRoleWhat they receive
ShameSham comparatorNot described
Receives: Device: Diagnostic sequence
Treatment AExperimentalNot described
Receives: Device: Therapeutic sequence; Device: Diagnostic sequence
Treatment BExperimentalNot described
Receives: Device: Therapeutic sequence; Device: Diagnostic sequence

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the 6 months follow up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935383
Sponsor's protocol ID
2503
Acronym
REVITALISE
Status last verified
Mar 2025
First submitted
17 Apr 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Therapeutic sequence and Diagnostic sequence in people with STEMI (ST Elevation MI), run by CorFlow Therapeutics AG.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giovanna Catalano (+41 41 399 18 09, gcatalano@corflow.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delta LVEF at post procedure and 6 months follow up visit (time frame: From enrollment to the 6 months follow up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in