STEMI - ST Elevation Myocardial InfarctionPiCSO-AMI-VNCT04958421
A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction.
A study testing PiCSO Impulse System in people with STEMI - ST Elevation Myocardial Infarction and Inferior Wall Myocardial Infarction, run by Miracor Medical SA at 11 sites in 5 countries.
Trial summary
The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Inferior 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
- 25 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 14 Feb 2022to 6 Feb 2023
- 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
- Right dominance with culprit lesion in mid or proximal RCA
- Pre-PCI TIMI flow 0 or 1 in the culprit lesion
- Symptom onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
- ECG evidence of acute inferior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous inferior precordial ECG leads (II, III, AVF) 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 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%
- Large left anterior descending artery providing blood supply beyond the left ventricular apex (supplying part of the inferior wall) as judged by angiography.
- Known allergy to polyurethanes, PET or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately premedicated
- Known pregnancy or breastfeeding
Show all 23Show fewer
- Known large pericardial effusion or cardiac tamponade
- Known hemodynamically relevant left to right and right to left shunt
- Previous CABG
- Known neurologic abnormality such as tumor or 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 GU or GI bleed (within 3 months)
- Administration of fibrinolytic therapy within 24 hours prior to enrollment
- Cardiogenic shock (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
- 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
- COPD with home oxygen therapy or on chronic steroid therapy for COPD
- Unconscious on presentation
- Patients under judicial protection, legal guardianship or curatorship
- Patient 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
- Any evidence of active infectious disease, or definite or probable COVID-19 diagnosis within the prior 4 weeks.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
France3 sites
CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
Bordeaux
Centre Hospitalier Régional Universitaire de Lille
Lille
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31059
United Kingdom3 sites
Golden Jubilee National Hospital
Clydebank
New Edinburgh Royal Infirmary
Edinburgh
John Radcliffe Hospital
Oxford, OX3 9DU
Denmark2 sites
Aarhus Universitetshospital
Aarhus
Odense Universitetshospital
Odense
Switzerland2 sites
Bern University Hospital
Bern
EOC Ospedale Regionale di Lugano - Civico
Lugano
About this study
Official title: A Randomized, Controlled, Pilot Study to Evaluate Safety and Feasibility of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction Presenting With TIMI 0 or 1 and Symptom Duration ≤ 12 Hours Treated Adjunct to Percutaneous Coronary Intervention (PCI) Compared to Standard PCI.
The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.
Read the detailed description
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pilot study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours treated adjunct to percutaneous coronary intervention (PCI) compared to standard PCI. Patients with an ST-segment elevated inferior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-V Inferior 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 for a FU visit at 12-36 hours, 30 days, 6 months and 1 year post index procedure. 12-36 hours and 6 months post index the patient will get a echocardiogram. At every FU 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, Inferior 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.
Adverse Device Effect (ADE) rate at 30 days post index procedure
Adverse Device Effect (ADE) rate at 30 days post index procedure
Measured: 30 days post MI
Secondary outcomes (11)
A severity index derived as the mean wall motion score within the region of AWM
- Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Measured: 12 to 36 hours and 6 months post MI
Ejection fraction using measured by Simpson's method with 2 apical view
- Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Measured: 12 to 36 hours and 6 months post MI
The absolute size of the region of abnormal wall motion (AWM)
- Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Measured: 12 to 36 hours and 6 months post MI
Percentage of the endocardium involved (%AWM)
- Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Measured: 12 to 36 hours and 6 months post MI
Wall motion score
- Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Measured: 12 to 36 hours and 6 months post MI
hs-Troponin
Maximum and AUC of hs-Troponin
Measured: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
C-reactive protein
Maximum, AUC and velocity of C-reactive protein
Measured: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
CK-MB
Maximum and AUC of CK-MB
Measured: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
Blushing index
Blushing index at the end of the procedure
Measured: Immediately after treatment
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 presented as % of subjects
Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start14 Feb 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
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, pilot stage study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miracor Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Banning, Prof., Principal investigator, John Radcliffe Hospital, Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958421
- Sponsor's protocol ID
- MIR-CIP 0005
- Acronym
- PiCSO-AMI-V
- Status last verified
- Apr 2022
- First submitted
- 29 Jun 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- 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 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Pilot Study to Evaluate Safety and Feasibility of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction Presenting With TIMI 0 or 1 and Symptom Duration ≤ 12 Hours Treated Adjunct to Percutaneous Coronary Intervention (PCI) Compared to Standard PCI.
- ClinicalTrials.gov ID
- NCT04958421
- Acronym / sponsor ID
- PiCSO-AMI-V / MIR-CIP 0005
- Keywords
- PiCSO, PiCSO Impulse System
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of financing
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Miracor Medical SAIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 12 Jul 2021 (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 safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.
Detailed description
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pilot study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours treated adjunct to percutaneous coronary intervention (PCI) compared to standard PCI. Patients with an ST-segment elevated inferior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-V Inferior 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 for a FU visit at 12-36 hours, 30 days, 6 months and 1 year post index procedure. 12-36 hours and 6 months post index the patient will get a echocardiogram. At every FU visit safety data and health status will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, controlled, parallel-groups, pilot stage study
| 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
- Right dominance with culprit lesion in mid or proximal RCA
- Pre-PCI TIMI flow 0 or 1 in the culprit lesion
- Symptom onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
- ECG evidence of acute inferior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous inferior precordial ECG leads (II, III, AVF) in men or ≥ 1.5 mm (0.15 mV) in women
Key exclusion criteria (23 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%
- Large left anterior descending artery providing blood supply beyond the left ventricular apex (supplying part of the inferior wall) as judged by angiography.
- Known allergy to polyurethanes, PET or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately premedicated
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
Adverse Device Effect (ADE) rate at 30 days post index procedure
Time frame: 30 days post MI
Adverse Device Effect (ADE) rate at 30 days post index procedure
11 secondary outcomes
A severity index derived as the mean wall motion score within the region of AWM
Time frame: 12 to 36 hours and 6 months post MI
Ejection fraction using measured by Simpson's method with 2 apical view
Time frame: 12 to 36 hours and 6 months post MI
The absolute size of the region of abnormal wall motion (AWM)
Time frame: 12 to 36 hours and 6 months post MI
Percentage of the endocardium involved (%AWM)
Time frame: 12 to 36 hours and 6 months post MI
Wall motion score
Time frame: 12 to 36 hours and 6 months post MI
hs-Troponin
Time frame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
C-reactive protein
Time frame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
CK-MB
Time frame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
Blushing index
Time frame: Immediately after treatment
ST-segment resolution
Time frame: 60-90 minutes post flow restoration
Device success and procedural success rate presented as % of subjects
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Study terminated due to lack of financing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- 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.
Adrian Banning, Prof. principal investigator
John Radcliffe Hospital, Oxford
11 sites in 5 countries: see every site and its status.
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 Inferior Wall Myocardial Infarction, run by Miracor Medical SA at 11 sites in 5 countries.
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 23 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: stopped early, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, United Kingdom, Denmark, Switzerland, Latvia. 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.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of financing). Results are not available in the source record.
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?
Adverse Device Effect (ADE) rate at 30 days post index procedure (time frame: 30 days post MI). 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 8 Mar 2023.