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

Withdrawn

• Conditions: STEMI - ST Elevation Myocardial Infarction; Anterior MI
• Interventions: Device: PiCSO

• Registration Number: NCT04566289
• Lead Sponsor: Miracor Medical SA

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.

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Status Verified: 2022-08
• Study Start: 2022-10-01
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PiCSO treatment group	PiCSO	PiCSO treatment as per IFU

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden; 🇩🇪 Dresden, Germany