STEMI - ST Elevation Myocardial InfarctionPhase 1MOCANCT03654573
The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment
A Phase 1 study of STEMI - ST Elevation Myocardial Infarction and Microvascular Obstruction, run by CorFlow Therapeutics AG at 8 sites in 3 countries.
Trial summary
First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Microvascular Obstruction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 4 Jun 2019to 18 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Major Inclusion Criteria:
- Patients 18 years of age or older presenting with ST-elevation myocardial infarction in the left anterior descending artery (LAD) undergoing primary percutaneous coronary intervention.
- Competent mental condition to provide signed and dated ethics committee approved study consent prior to study related procedures
- Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIa inhibitors
- Referred for primary PCI within 5 hours of symptom onset with evidence of continuing ischemia and symptom to balloon time not exceeding 6 hours
Major Exclusion Criteria:
- Unconsciousness
- Previous bypass graft surgery
- Contraindication to CMRI
- Recent or current major bleeding within 30 days prior to intervention
- Recent major surgery within 30 days prior to intervention
- End-stage heart failure with inotrope support and/or consideration for LVAD or heart transplant
- Transient ischemic attack or stroke within 30 days prior to intervention
- Pregnant or females of childbearing potential
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Switzerland5 sites
Inselspital Bern
Bern, Canton of Bern
HUG Geneva
Geneva
CHUV Lausanne
Lausanne
Cardiocentro Ticino
Lugano, Canton Ticino, 6900
UniversitätsSpital Zürich
Zurich, 8091
Lithuania2 sites
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
Kaunas, 50161
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
About this study
First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
- Being tested
- CorFlow Controlled Flow Infusion System - CoFI™
- 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.
CorFlow Controlled Flow Infusion System - CoFI™Device
The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | Experimental | Adult subjects presenting with STEMI in the LAD undergoing PPCI Receives: Device: CorFlow Controlled Flow Infusion System - CoFI™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of study device or study procedure adverse effect or event
Safety Objective is the incidence of study device or study procedure adverse effect or event at up to 30 days. To assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Measured: up to 30 days
Secondary outcomes (2)
Diagnostic Success
Ability to perform a diagnostic sequence and to calculate a base flow resistance curve
Measured: 0 days
Therapeutic Success
Ability to perform the therapeutic sequence as described in the CIP
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start4 Jun 2019
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- N= 50 Diagnostic and N= 20 Therapeutic
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorFlow Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lukas Hunziker, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654573
- Sponsor's protocol ID
- 1801
- Acronym
- MOCA
- Status last verified
- Mar 2025
- First submitted
- 16 Aug 2018
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment
- ClinicalTrials.gov ID
- NCT03654573
- Acronym / sponsor ID
- MOCA / 1801
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- CorFlow Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- N= 50 Diagnostic and N= 20 Therapeutic
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | Experimental | Device: CorFlow Controlled Flow Infusion System - CoFI™Adult subjects presenting with STEMI in the LAD undergoing PPCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorFlow Controlled Flow Infusion System - CoFI™The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement. | Device | STEMI patients |
Primary outcome
The incidence of study device or study procedure adverse effect or event
Time frame: up to 30 days
Safety Objective is the incidence of study device or study procedure adverse effect or event at up to 30 days. To assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
2 secondary outcomes
Diagnostic Success
Time frame: 0 days
Therapeutic Success
Time frame: 0 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Hunziker principal investigator
Insel Gruppe AG, University Hospital Bern
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of STEMI - ST Elevation Myocardial Infarction and Microvascular Obstruction, run by CorFlow Therapeutics AG at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Lithuania, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of study device or study procedure adverse effect or event (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.