Anterior MI, STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
PiCSO, PiCSO Impulse System
Brief summary
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.
Detailed description
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.
Interventions
DEVICEPiCSO
Percutaneous coronary intervention
Sponsors
Miracor Medical SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. Culprit lesion in proximal or mid LAD 3. ST-segment elevation 4. Pre-PCI TIMI flow 0 or 1. 5. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h. 6. Patient is deemed eligible for PCI 7. Consent as per approved national ethical committee specific requirements prior to the procedure.
Exclusion criteria
1. Patients with contraindications to percutaneous insertion or angiography 2. Patients with implants or foreign bodies in the coronary sinus 3. Known allergy to polyurethanes, PET or stainless steel 4. Known pregnancy or breast feeding 5. Known pericardial effusion or cardiac tamponade 6. Known central hemodynamically relevant left/right shunt 7. Patients with symptom onset \> 12 hours 8. Patients with previous CABG 9. Patients with a history of stroke, TIA or reversible ischemic neurological deficit within last 6 month. 10. Patients with coagulopathy 11. Patients under judicial protection, legal guardianship or curatorship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Effect (ADE) rate at 30 days post index procedure PCI | 30 days | Adverse Device Effect (ADE) rate at 30 days post index procedure PCI |
Countries
Germany
Outcome results
None listed