NCT05864248

Feasibility Study SA of the Supira System for HRPCI

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Supira Medical · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).

Detailed description

The Feasibility Study SA is a prospective, single-arm, interventional multi-center study enrolling up to 100 treated subjects. The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta. The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option

Conditions

• Heart Diseases
• Coronary Artery Disease (CAD)
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Supira System	The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.

Timeline

• Start date: 2023-09-13
• Primary completion: 2025-04-30
• Completion: 2026-03-30
• First posted: 2023-05-18
• Last updated: 2026-02-09

Locations

2 sites across 1 country: Brazil