Feasibility Study SA of the Supira System for HRPCI

Not Applicable

Recruiting

• Conditions: Heart Diseases; Coronary Artery Disease (CAD); Heart Failure
• Interventions: Device: Supira System

• Registration Number: NCT05864248
• Lead Sponsor: Supira Medical

Brief 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

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-18
• Study Start: 2023-09-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRPCI patients	Supira System	Patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Primary Outcome Measures

Name	Time	Method
Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.	From device delivery through device removal (up to 4 hours).	Sustained hypotension is defined as sustained mean arterial pressure (MAP) \< 60mmHg requiring (1) more than one administration of inotropes/vasopressors within 5 minutes, OR (2) continuous infusion of inotropic/pressor medications, OR 3) alternative mechanical circulatory support, to restore hemodynamics.
Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal.	From device delivery through device removal (up to 4 hours).	MDRAEs related to the device.

Secondary Outcome Measures

Name	Time	Method
Rate of Technical Success.	From device delivery through device removal (up to 4 hours).	Completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful retrieval of the catheter.
Rate of Procedural Success	From device delivery through device removal (up to 4 hours).	Rate of technical success without procedural serious adverse events (SAEs).
Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever comes first.	From device removal through hospital discharge or 72 hours post-procedure, whichever occurs first.	MDRAEs related to the study device.
Rate of composite MDRAE from hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.	From hospital discharge or 72 hours post-procedure (whichever occurs first)	Major adverse events related to the study device.
Rate of composite MDRAE from 30 days to 90 days post device removal (for subjects enrolled and treated after the first 30 subjects).	From 30 days to 90 days post device removal.	Major adverse events related to the device.

Trial Locations

Locations (2)

Instituto Dante Pazzanese De Cardiologia (Dante); 🇧🇷 São Paulo, Brazil

'Instituto Do Coração de São Paulo (InCor)'; 🇧🇷 São Paulo, Brazil