PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.

Official Title
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Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study

Conditions
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ST Elevation (STEMI) Myocardial Infarction

Intervention / Treatment
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* Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time anterior STEMI defined by the following: Symptoms of myocardial ischemia > 30 minutes and < 12 hours ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG 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 investigator preclude participation in the trial) Exclusion Criteria: Younger than 18 years of age Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct Left main coronary artery culprit lesion 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 Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles) Cardiac arrest requiring chest compression or resuscitation Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis History of stroke, TIA or reversible ischemic neurological disease within last 6 months Left bundle branch block Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.) Presence of any lead in the coronary sinus Active or treated malignancies in the last 12 months Previous coronary artery bypass graft surgery Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L) Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions Participation in another ongoing clinical study Women of child-bearing age Non-cardiac comorbidities and life expectancy < 1 year Legal incompetence A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures No dependents neither to the sponsor nor to the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PICSO<br>PICSO treatment for 90 minutes | Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion<br>* The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.<br>* Other names: PICSO Impulse Console;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful delivery of PICSO treatment | Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI measurement of infarct size | Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up | 4 months | 
| Assessment of left ventricular function | Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days | 4 months | 
| Assessment of microvascular perfusion | Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days | 4 months | 
| Resolution of ST-segment elevation | 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 | 24 hours | 
| Measurement of ST segment time curve area | ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording. | 3 hours | 
| Number of adverse events | Safety endpoints recorded are Major Adverse Cardiac Events (MACE), Major Adverse Cardiac and Cerebrovascular Events (MACCE), net adverse clinical events (MACE and bleeding), Serious and non serious Adverse Device Events ((S)ADE) rates | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, PICSO, Coronary Sinus, Involving Left Anterior Descending Coronary Artery