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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— PiCSO-AMI-IV  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04566289
• Other study ID #: MIR-CIP 0004
• Status: Withdrawn
• Start date: October 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2022
• Source: Miracor Medical SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Device:
• PiCSO
Percutaneous coronary intervention

Locations

Country	Name	City	State
Germany	Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Miracor Medical SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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