Microvascular Obstruction (MVO)MOCA IINCT06909578
Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II
A study of Microvascular Obstruction (MVO) and STEMI - ST Elevation Myocardial Infarction, run by CorFlow Therapeutics AG.
Trial summary
A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Obstruction (MVO), STEMI - ST Elevation Myocardial Infarction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- 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:
- Subject ≥18 years of age
- Ability to provide written informed consent according to GCP and governing regulations
- Diagnosis of acute anterior STEMI
- Persistent symptoms to balloon time ≤ 6 hours. The assessment by the treating investigator after evaluation by subjects explanation is the defining timepoint for symptom onset.
- PPCI \& Angiographic
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- Culprit lesion in the LAD
- COFI ballon can be placed according to IFU
- Required stent diameter ≥ 2.75 mm and ≤ 5mm
- Required stent length ≥ 15 mm
- Successful PPCI Procedure as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.
Who cannot join
- Clinical:
- Cardiogenic shock
- Thrombolytic therapy administered for this STEMI
- Contraindication to CMRI
- Cardiac pacemaker or implantable defibrillator;
- Non-MRI compatible aneurysm clip;
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- 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.
- Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, VSD, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or insufficiency, pericardial disease
- Major bleeding ≤ 30d prior to intervention
- Major surgery ≤ 30d prior to intervention
- TIA or stroke ≤ 30d prior to intervention
- Heart failure with inotrope support and/or consideration for LVAD or heart transplant
- Known severe renal disease with creatinine > 2.5 mg/dL and/or eGFR < 30 mL/min/1.73 m2
- 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
- Pregnancy
- PPCI \& Angiographic:
- CABG of LAD
- Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification)
- Cardiac condition preventing the use of the CoFI System
- Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb/IIIa inhibitors or adenosine
- Cardiac condition mandating elective PCI/CABG procedure prior to CMRI
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations.
Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.
Read the detailed description
Microvascular obstruction (MVO) is a common complication that occurs after establishing coronary vessel patency by percutaneous coronary intervention (PCI) for the treatment of acute myocardial infarction (AMI).
Despite the successful restoration of vessel patency through PCI, 50% to 70% of STEMI subjects experience MVO, which affects vessels in the myocardial microcirculation. MVO occurs most commonly in the setting of AMI because the prolonged ischemia leads to endothelial damage, myocyte oedema and microvascular dysfunction.
Research has shown that MVO increases the risk of poor clinical outcomes, including death, re-infarction, reduced left ventricular ejection fraction (LVEF), left ventricular (LV) remodeling, heart failure, and more.
Late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) is the current state-of-the-art for MVO identification and quantification. However, due to clinical reasons, CMRI imaging cannot be performed during the subject's emergent state. In most cases, this means that the diagnosis is made outside the biological window where MVO-related damage to heart muscle could be reversed or at least reduced.
Thus, although CMRI is the most accurate method to diagnose MVO, its use in routine practice is limited. Therefore, a direct and accurate quantitative diagnosis during primary PCI is required for early risk stratification in routine clinical practice.
The Controlled Flow Infusion (CoFI) system is designed to be integrated into current PCI protocols, enabling the rapid and safe detection of MVO after successful PCI procedures. Using a proprietary algorithm, the system can provide an output for diagnosing microvascular obstruction (MVO) immediately post-PCI by measuring real-time distal coronary back-pressure response to a dynamic infusion sequence downstream of a low-pressure occlusion balloon.
The aim of the study is to validate the diagnostic performance of the CoFI system in detecting MVO in anterior STEMI subjects following PPCI as measured in CMRI 1-3 days post-procedure.
The study has two phases 1 \& 2. Phase 1 aims to demonstrate whether the pCoFI threshold for MVO detection gathered in the US population aligns with the 95% confidence interval (CI) of the pCoFI threshold from the EU population gathered in the FIH MOCA-I study. Phase 2 has two possible routes, A or B. Depending on the outcome of phase 1, the study will continue along either route. The study progresses into pivotal route A if the threshold 95% CI aligns as described above and into route B if it does not. If the study follows route B the threshold will be reset and the sample size recalculated. In case of route B phase 1 data will become part of the data training set, whereas in route A would phase 1 data will be included in the study analysis set.
With a need to follow Route B, comes a substantial clinical investigation plan (CIP) amendment/supplement submission to the FDA and applicable IRBs, before restarting the study.
The sample size for the MOCA-II feasibility and pivotal phases will be based on a conservative assumed disease prevalence of 50% MVO+.
Interim Analysis An interim analysis is planned to be done after 50% of the subjects have been enrolled to verify if the study's success or futility criteria are met.
Based on the interim analysis, the sample size for the primary endpoint may be adjusted according to the actual MVO prevalence from the study data set, as defined by CMRI at 1 to 3 days post-PPCI. The observed prevalence and interim estimates of sensitivity and specificity will be used to reassess the required sample size if the interim study data do not justify an early stop for success.
- 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 |
|---|---|---|
| Adult subjects presenting with STEMI in the LAD undergoing PPCI | Other | Not described 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.
Primary Effectiveness Endpoint
Diagnostic performance is measured by sensitivity and specificity of the CoFI system in detecting MVO in relation to the pre-set PCoFI threshold of 124 mmHg. The analysis will be per-protocol (PP) (primary) and the full analysis set (FAS) (secondary).
Hypothesis
Sensitivity and Specificity will be tested to meet the acceptance criteria:
i.The lower bound of the confidence interval (CI) for sensitivity is 70% ii. The lower bound of the CI for specificity is 65% H0: p < p0 H1: p ≥ p0 p0 = 70%se, 65%sp
Measured: From enrollment to the end of treatment at 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Obstruction (MVO)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorFlow Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909578
- Sponsor's protocol ID
- 2402
- Acronym
- MOCA II
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Decide has to made by study leadership.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II
- ClinicalTrials.gov ID
- NCT06909578
- Acronym / sponsor ID
- MOCA II / 2402
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CorFlow Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Apr 2025 (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.
A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations.
Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.
Detailed description
Microvascular obstruction (MVO) is a common complication that occurs after establishing coronary vessel patency by percutaneous coronary intervention (PCI) for the treatment of acute myocardial infarction (AMI).
Despite the successful restoration of vessel patency through PCI, 50% to 70% of STEMI subjects experience MVO, which affects vessels in the myocardial microcirculation. MVO occurs most commonly in the setting of AMI because the prolonged ischemia leads to endothelial damage, myocyte oedema and microvascular dysfunction.
Research has shown that MVO increases the risk of poor clinical outcomes, including death, re-infarction, reduced left ventricular ejection fraction (LVEF), left ventricular (LV) remodeling, heart failure, and more.
Late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) is the current state-of-the-art for MVO identification and quantification. However, due to clinical reasons, CMRI imaging cannot be performed during the subject's emergent state. In most cases, this means that the diagnosis is made outside the biological window where MVO-related damage to heart muscle could be reversed or at least reduced.
Thus, although CMRI is the most accurate method to diagnose MVO, its use in routine practice is limited. Therefore, a direct and accurate quantitative diagnosis during primary PCI is required for early risk stratification in routine clinical practice.
The Controlled Flow Infusion (CoFI) system is designed to be integrated into current PCI protocols, enabling the rapid and safe detection of MVO after successful PCI procedures. Using a proprietary algorithm, the system can provide an output for diagnosing microvascular obstruction (MVO) immediately post-PCI by measuring real-time distal coronary back-pressure response to a dynamic infusion sequence downstream of a low-pressure occlusion balloon.
The aim of the study is to validate the diagnostic performance of the CoFI system in detecting MVO in anterior STEMI subjects following PPCI as measured in CMRI 1-3 days post-procedure.
The study has two phases 1 \& 2. Phase 1 aims to demonstrate whether the pCoFI threshold for MVO detection gathered in the US population aligns with the 95% confidence interval (CI) of the pCoFI threshold from the EU population gathered in the FIH MOCA-I study. Phase 2 has two possible routes, A or B. Depending on the outcome of phase 1, the study will continue along either route. The study progresses into pivotal route A if the threshold 95% CI aligns as described above and into route B if it does not. If the study follows route B the threshold will be reset and the sample size recalculated. In case of route B phase 1 data will become part of the data training set, whereas in route A would phase 1 data will be included in the study analysis set.
With a need to follow Route B, comes a substantial clinical investigation plan (CIP) amendment/supplement submission to the FDA and applicable IRBs, before restarting the study.
The sample size for the MOCA-II feasibility and pivotal phases will be based on a conservative assumed disease prevalence of 50% MVO+.
Interim Analysis An interim analysis is planned to be done after 50% of the subjects have been enrolled to verify if the study's success or futility criteria are met.
Based on the interim analysis, the sample size for the primary endpoint may be adjusted according to the actual MVO prevalence from the study data set, as defined by CMRI at 1 to 3 days post-PPCI. The observed prevalence and interim estimates of sensitivity and specificity will be used to reassess the required sample size if the interim study data do not justify an early stop for success.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult subjects presenting with STEMI in the LAD undergoing PPCI | Other | Device: CorFlow Controlled Flow Infusion System - CoFI™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical:
- PPCI \& Angiographic
- Culprit lesion in the LAD
- COFI ballon can be placed according to IFU
- Required stent diameter ≥ 2.75 mm and ≤ 5mm
Key exclusion criteria (29 listed)
- Clinical:
- CABG of LAD
- Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification)
- Cardiac condition preventing the use of the CoFI System
- Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb/IIIa inhibitors or adenosine
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 | Adult subjects presenting with STEMI in the LAD undergoing PPCI |
Primary outcome
Primary Effectiveness Endpoint
Time frame: From enrollment to the end of treatment at 6 Months
Diagnostic performance is measured by sensitivity and specificity of the CoFI system in detecting MVO in relation to the pre-set PCoFI threshold of 124 mmHg. The analysis will be per-protocol (PP) (primary) and the full analysis set (FAS) (secondary). Hypothesis Sensitivity and Specificity will be tested to meet the acceptance criteria: i.The lower bound of the confidence interval (CI) for sensitivity is 70% ii. The lower bound of the CI for specificity is 65% H0: p < p0 H1: p ≥ p0 p0 = 70%se, 65%sp
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No. Decide has to made by study leadership.
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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.
Questions about this trial
What is this clinical trial studying?
A study of Microvascular Obstruction (MVO) and STEMI - ST Elevation Myocardial Infarction, 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 29 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 10 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Reginald D Walton, MBA (2544241252, rwalton@corflow.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: From enrollment to the end of treatment at 6 Months). 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 10 Jul 2025.