Acute myocardial infarction
Conditions
Interventions
All included patiénts will receive adjuvant PICSO treatment. This contains the
insertion of the PICSO Impulse catheter through a femoral vein puncture en the
administration of the PICSO treatment fo
Sponsors
Miracor Medical Systems GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.First time anterior STEMI defined by the following: a.Symptoms of myocardial ischemia > 30 minutes and 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG. 2.Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the operator preclude participation in the trial)
Exclusion criteria
Exclusion criteria: 1.Younger than 18 years of age 2.Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct 3.Left main coronary artery culprit lesion 4.Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure 5.Cardiogenic shock (systolic blood pressure *90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the feasibility of PICSO in STEMI patients defined as the successful delivery of the PICSO Impulse catheter and successful administration of PICSO treatment for 90 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 1. ST-segment time curve area for the first 3 hours on 24 hour continuous 12-lead ECG Holter monitor recording. 2. Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120 minutes after last contrast injection prior to PICSO placement procedure on 24 hour continuous 12-lead ECG Holter monitor recording. 3. Microvascular perfusion assessed by MRI between 2-5 days post-primary PCI procedure and at 120±14 days follow-up. 4. Infarct size assessed by MRI between 2-5 days after primary PCI and at 120±14 days follow-up. 5. Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120±14 days follow-up. Safety Endpoints: 1. Major adverse cardiac events (MACE) 2. Major adverse cardiac and cerebrovascular events (MACCE) 3. Net adverse clinical events (MACE + Bleeding) 4. (Severe) Adverse Device Event ((S)ADE) rates Exploratory MRI endpoints: 1. Microvascular obstruction (in grams and percentage of total left ventricular mass and percentage of total infarct mass) assessed by MRI between 2-5 days post-primary PCI procedure and at 120±14 days follow-up. 2. Left ventricular ejection fraction (%), left ventricular end-diastolic volume (mL), and left ventricular end-systolic volume (mL) at 2-5 days and at 120±14 days. 3. Transmural extent of infarction (%). | — |
Countries
Netherlands
Outcome results
None listed