STEMI - ST Elevation Myocardial InfarctionPiCSO-AMI-IINCT05497011
A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients
A study testing PiCSO Impulse System in people with STEMI - ST Elevation Myocardial Infarction and Anterior Wall Myocardial Infarction, run by Miracor Medical SA.
Trial summary
The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction
- What is being tested?
- PiCSO Impulse System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 30 Jun 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years old
- Culprit lesion in proximal or mid left anterior descending artery (LAD)
- Pre-PCI TIMI flow 0, 1 or 2
- Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
- Electrocardiogram (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
- Emergent PCI will be performed according to national and local hospital guidelines
- Consent per approved national IRB/EC specific requirements prior to the procedure.
Who cannot join
- Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
- Implants or foreign bodies in the coronary sinus
- Left main disease >= 50%
- Need for treatment of any vessel other than the LAD (or its branches) during the index procedure or before the 5 ± 2 days study CMR.
- Known allergy to polyurethanes, polyethylene terephthalate (PET) or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately pre-medicated
- Known pregnancy or breastfeeding
Show all 24Show fewer
- Known large pericardial effusion or cardiac tamponade
- Known hemodynamically relevant left to right and right to left shunt
- Known previous myocardial infraction (MI)
- Previous coronary artery bypass graft (CABG)
- Known neurologic abnormality such as tumor or arteriovenous (AV) malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent genitourinary (GU) or gastrointestinal (GI) bleed (within 3 months)
- Administration of fibrinolytic therapy within 24 hours prior to enrollment
- Cardiogenic shock (systolic blood pressure (SBP) < 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
- Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
- Patient not suitable for femoral vein access
- Contraindication to cardiac magnetic resonance imaging CMR (e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance)
- Active participation in another drug or device investigational study that has not reached its primary endpoint
- Known severe kidney disease (eGFR <=30 mL/min/1.73 m2 by MDRD formula) or on hemodialysis
- Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy
- Unconscious on presentation
- Patients under judicial protection, legal guardianship or curatorship
- 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 protocol, confound the data interpretation, or is associated with limited life expectancy of less than 1 year
- Patients with definite or probable COVID-19 diagnosis > 4 weeks prior to the current MI unless they had returned to their baseline state of health after recovery from the COVID-19 illness
About this study
Official title: A Randomized Controlled Study to Evaluate the Safety and Efficacy of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Anterior STEMI Patients With TIMI 0-2 at Presentation.
The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).
Read the detailed description
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pivotal study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with acute anterior ST-segment elevation myocardial infarction (STEMI), presenting with thrombolysis in myocardial infarction (TIMI) 0, 1, or 2 and symptom duration ≤ 12 hours treated adjunct to PCI compared to standard PCI. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-II anterior STEMI study. After consent as per approved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After TIMI flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. In the event the PiCSO Impulse Catheter cannot be placed in the CS within 30 minutes, the physician should proceed with the regular PCI and the PiCSO treatment will be considered a failure. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed. The patient is seen at 5 days and 6 months for cardiovascular magnetic resonance imaging (CMR). Follow-up visits will take place at day 5, day 30, 6 months, 1 year, 2 years and 3 years. At every follow-up visit safety data and health status will be documented.
- Being tested
- PiCSO Impulse System
- Keywords
- PiCSO, PiCSO Impulse System
- Medical subject headings
- ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCSO Impulse SystemDevice
After blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention. |
| PiCSO | Experimental | This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention). Receives: Device: PiCSO Impulse System |
What is being measured
The primary outcome is the main question the study is designed to answer.
12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days
Primary safety endpoint is based on a 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days post treatment in patients randomized to PiCSO Group in which the PiCSO treatment was delivered or attempted to be delivered. These events will consist of the composite of:
- Femoral venous access site complications:
- Major bleed (BARC 3-5)
- Infections requiring systemic (oral or intravenous) antibiotic treatment
- Any femoral access site-related events requiring surgery
- Coronary sinus dissection requiring percutaneous intervention or surgery
- Pericardial effusion or tamponade requiring percutaneous intervention or surgery
- Embolization or Thrombosis
- Stroke
Measured: 30 days post index PCI
Difference in myocardial infarct size
Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of left ventricular (LV) mass) between the PiCSO Group and the Control Group, assessed by CMR at 5±2 days post index PCI.
Measured: 5 days post index PCI
Secondary outcomes (12)
Major Adverse Cardiac Event (MACE) at 30 days as well as 1, 2 and 3 years post index PCI
MACE at 30 days as well as 1, 2 and 3 years post index PCI
- Cardiovascular death
- Cardiovascular hospitalization
- Heart failure (HF) hospitalization
- New onset or worsening HF
Measured: 30 days, 1, 2 and 3 years post index PCI
Individual components of the MACE
Individual components of the MACE to be evaluated at 30 days as well as 6 months and 1, 2 and 3 years post index PCI
Measured: 30 days, 1, 2 and 3 years post index PCI
Classification of all-cause death
Classification of all-cause death at 30 days as well as 6 months and 1, 2 and 3 years post index PCI into the following categories:
- Cardiac cause of death
- Non-cardiac cause of death
- Death of Undetermined Cause
Measured: 30 days, 6 months, 1, 2 and 3 years post index PCI
Time to death and heart failure hospitalization
The hierarchical composite of time to death within 1 year, time to heart failure hospitalization within one 1-year and infarct size at assessed by CMR at 5±2 days post index PCI.
Measured: 1 year post index PCI
Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
Measured: 6 months post index PCI
Occurrence and extent of microvascular obstruction and hemorrhage
Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI
Measured: 5 days post index PCI
Myocardial function (LVEF, LVESV, LVEDV)
Myocardial function (Left ventricular ejection fraction (LVEF), Left ventricular end-diastolic volume (LVEDV) and Left ventricular end-systolic volume (LVESV)) assessed by CMR at 5 days and 6 months post index PCI
Measured: 5 days and 6 months post index PCI
Myocardial Salvage Index and myocardial infarct size
Myocardial Salvage Index at 5 days and 6 months post index PCI (derived from Area at Risk (AAR) assessed by CMR at 5 days and myocardial infarct size (% of LV mass) assessed by CMR at 5 days or 6 months, respectively)
Measured: 5 days and 6 months post index PCI
ST-segment resolution
ST-segment resolution at 60-90 minutes post flow restoration
Measured: 60-90 minutes post flow restoration
Device success and procedural success rate
Device success and procedural success rate presented as % of subjects
Measured: Baseline (treatment day)
Changes in quality of life
Changes in quality of life measured by EQ-5D at 5 days, 6 months and 1, 2, 3 years post index PCI
Measured: 30 days, 6 months and 1, 2, 3 years post index PCI
Utilization of health resources
Assess health economics by collecting the utilization of health resources throughout the study duration
Measured: 30 days, 6 months and 1, 2, 3 years post index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start30 Mar 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Study terminated due to lack of financing
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, controlled, parallel-groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miracor Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg W. Stone, Prof., Principal investigator, Mount Sinai, New York, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497011
- Sponsor's protocol ID
- MIR-CIP 0003
- Acronym
- PiCSO-AMI-II
- Status last verified
- Mar 2023
- First submitted
- 8 Aug 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Safety and Efficacy of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Anterior STEMI Patients With TIMI 0-2 at Presentation.
- ClinicalTrials.gov ID
- NCT05497011
- Acronym / sponsor ID
- PiCSO-AMI-II / MIR-CIP 0003
- Keywords
- PiCSO, PiCSO Impulse System
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to lack of financing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Miracor Medical SAIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Aug 2022 (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.
The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).
Detailed description
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pivotal study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with acute anterior ST-segment elevation myocardial infarction (STEMI), presenting with thrombolysis in myocardial infarction (TIMI) 0, 1, or 2 and symptom duration ≤ 12 hours treated adjunct to PCI compared to standard PCI. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-II anterior STEMI study. After consent as per approved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After TIMI flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. In the event the PiCSO Impulse Catheter cannot be placed in the CS within 30 minutes, the physician should proceed with the regular PCI and the PiCSO treatment will be considered a failure. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed. The patient is seen at 5 days and 6 months for cardiovascular magnetic resonance imaging (CMR). Follow-up visits will take place at day 5, day 30, 6 months, 1 year, 2 years and 3 years. At every follow-up visit safety data and health status will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, controlled, parallel-groups
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention. |
| PiCSO | Experimental | Device: PiCSO Impulse SystemThis arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Culprit lesion in proximal or mid left anterior descending artery (LAD)
- Pre-PCI TIMI flow 0, 1 or 2
- Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
- Electrocardiogram (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
Key exclusion criteria (24 listed)
- Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
- Implants or foreign bodies in the coronary sinus
- Left main disease >= 50%
- Need for treatment of any vessel other than the LAD (or its branches) during the index procedure or before the 5 ± 2 days study CMR.
- Known allergy to polyurethanes, polyethylene terephthalate (PET) or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately pre-medicated
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 |
|---|---|---|
| PiCSO Impulse SystemAfter blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed. | Device | PiCSO |
Primary outcome
12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days
Time frame: 30 days post index PCI
Primary safety endpoint is based on a 12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days post treatment in patients randomized to PiCSO Group in which the PiCSO treatment was delivered or attempted to be delivered. These events will consist of the composite of: * Femoral venous access site complications: * Major bleed (BARC 3-5) * Infections requiring systemic (oral or intravenous) antibiotic treatment * Any femoral access site-related events requiring surgery * Coronary sinus dissection requiring percutaneous intervention or surgery * Pericardial effusion or tamponade requiring percutaneous intervention or surgery * Embolization or Thrombosis * Stroke
Difference in myocardial infarct size
Time frame: 5 days post index PCI
Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of left ventricular (LV) mass) between the PiCSO Group and the Control Group, assessed by CMR at 5±2 days post index PCI.
12 secondary outcomes
Major Adverse Cardiac Event (MACE) at 30 days as well as 1, 2 and 3 years post index PCI
Time frame: 30 days, 1, 2 and 3 years post index PCI
Individual components of the MACE
Time frame: 30 days, 1, 2 and 3 years post index PCI
Classification of all-cause death
Time frame: 30 days, 6 months, 1, 2 and 3 years post index PCI
Time to death and heart failure hospitalization
Time frame: 1 year post index PCI
Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI
Time frame: 6 months post index PCI
Occurrence and extent of microvascular obstruction and hemorrhage
Time frame: 5 days post index PCI
Myocardial function (LVEF, LVESV, LVEDV)
Time frame: 5 days and 6 months post index PCI
Myocardial Salvage Index and myocardial infarct size
Time frame: 5 days and 6 months post index PCI
ST-segment resolution
Time frame: 60-90 minutes post flow restoration
Device success and procedural success rate
Time frame: Baseline (treatment day)
Changes in quality of life
Time frame: 30 days, 6 months and 1, 2, 3 years post index PCI
Utilization of health resources
Time frame: 30 days, 6 months and 1, 2, 3 years post index PCI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
Gregg W. Stone, Prof. principal investigator
Mount Sinai, New York, US
Questions about this trial
What is this clinical trial studying?
A study testing PiCSO Impulse System in people with STEMI - ST Elevation Myocardial Infarction and Anterior Wall Myocardial Infarction, run by Miracor Medical SA.
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 7 inclusion and 24 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: withdrawn, as of the sponsor's last update on 24 Mar 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days (time frame: 30 days post index PCI). The study lists 2 primary outcomes in all. 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 24 Mar 2023.