NCT04566289

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Miracor Medical SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	PiCSO	Percutaneous coronary intervention

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-31
• Completion: 2027-12-31
• First posted: 2020-09-28
• Last updated: 2023-03-08

Locations

1 site across 1 country: Germany