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

NCT ID: NCT04566289

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2027-12-31

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Anterior MI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PiCSO treatment group

PiCSO treatment as per IFU

PiCSO

Intervention Type: DEVICE

Percutaneous coronary intervention

Interventions

PiCSO

Percutaneous coronary intervention

Intervention Type: DEVICE

Other Intervention Names

PCI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miracor Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden

Dresden, , Germany

Countries

Germany

Other Identifiers

MIR-CIP 0004

Identifier Type: -

Identifier Source: org_study_id