Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance

Study Overview
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Brief Summary
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A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.

Detailed Description
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This is a observational registry study. Patients with an ST-segment elevated anterior infarct eligible for PCI and commercial PiCSO treatment will be invited to participate in the PiCSO-AMI-IV study. After having given consent as per approved ethics committee requirements, the PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS to start the PiCSO therapy. After the procedure the patient will be followed for safety assessments at 30 days, 6 months, 1 year, 2 year and 3 years post index procedure.

Official Title
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Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance

Conditions
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STEMI - ST Elevation Myocardial Infarction, Anterior MI

Intervention / Treatment
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* Device: PiCSO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Culprit lesion in proximal or mid LAD ST-segment elevation Pre-PCI TIMI flow 0 or 1. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h. Patient is deemed eligible for PCI Consent as per approved national ethical committee specific requirements prior to the procedure. Exclusion Criteria: Patients with contraindications to percutaneous insertion or angiography Patients with implants or foreign bodies in the coronary sinus Known allergy to polyurethanes, PET or stainless steel Known pregnancy or breast feeding Known pericardial effusion or cardiac tamponade Known central hemodynamically relevant left/right shunt Patients with symptom onset > 12 hours Patients with previous CABG Patients with a history of stroke, TIA or reversible ischemic neurological deficit within last 6 month. Patients with coagulopathy Patients under judicial protection, legal guardianship or curatorship.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PiCSO treatment group<br>PiCSO treatment as per IFU | Device: PiCSO<br>* Percutaneous coronary intervention<br>* Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Device Effect (ADE) rate at 30 days post index procedure PCI | Adverse Device Effect (ADE) rate at 30 days post index procedure PCI | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PiCSO, PiCSO Impulse System