Clinical trial NCT04566289: Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
Official title: Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: STEMI - ST Elevation Myocardial Infarction
Anterior MI
Keywords: PiCSO
PiCSO Impulse System
Lead sponsor: Miracor Medical SA
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of subjects presenting with acute myocardial infarction, pre-PCI TIMI flow 0 or 1 and symptom duration ≤ 12 h who are eligible for primary percutaneous coronary intervention as per IFU.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
Study officials:
References: