An interventional study of PiCSO Impulse System in STEMI - ST Elevation Myocardial Infarction and Anterior Wall Myocardial Infarction, sponsored by Miracor Medical SA. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Miracor Medical SA · Not applicable, Interventional, and Treatment
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).
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.
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Exclusion Criteria:
This is the actual control group receiving conventional therapy, ie. percutaneous coronary intervention.
This arm will be treated with Pressure controlled intermittent Coronary Sinus Occlusion (PiCSO) in addition to conventional therapy (percutaneous coronary intervention).
Device: PiCSO Impulse System
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.
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
Time frame: 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.
Time frame: 5 days post index PCI
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 5 days and 6 months post index PCI
ST-segment resolution
ST-segment resolution at 60-90 minutes post flow restoration
Time frame: 60-90 minutes post flow restoration
Device success and procedural success rate
Device success and procedural success rate presented as % of subjects
Time frame: 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
Time frame: 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
Time frame: 30 days, 6 months and 1, 2, 3 years post index PCI
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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