Feasibility Study SA of the Supira System for HRPCI

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Heart Failure; Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: Supira System

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04012-909
    • Instituto Dante Pazzanese De Cardiologia (Dante)
  • São Paulo, Brazil, 5403-000
    • 'Instituto Do Coração de São Paulo (InCor)'

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

To be eligible, subjects must meet ALL of the following inclusion criteria:

1. Age ≥ 18 and ≤ 90 years
2. Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
3. Signed the informed consent

To be eligible, subjects must NOT meet ANY of the following exclusion criteria:

1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic BP < 90 mmHg or the need for inotropes/pressors to maintain a systolic BP > 90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of intra-aortic balloon pump (IABP), or any other circulatory support device.
2. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
3. Evidence of left ventricular thrombus
4. Moderate or greater aortic valvular disease or regurgitation (≥ 2+ on a 4-grade scale as assessed on transthoracic echo cardiogram (TTE)
5. Moderate or greater aortic stenosis (gradient >20 mmHg or valve area < 1.5 cm^2 as assessed on TTE)
6. Previous aortic valve replacement or reconstruction
7. Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm
8. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device
9. Presence of decompensated liver disease; severe liver dysfunction (Child class C)
10. Patients requiring renal replacement therapy with dialysis
11. Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy
12. Current or history of heparin-induced thrombocytopenia (HIT)
13. Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors, or nitinol
14. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)
15. Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
16. Planned coronary intervention within 30 days post index procedure
17. Breastfeeding or pregnant
18. Currently participating in active follow-up phase of another clinical study of an investigational drug or device
19. Active COVID-related infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
20. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
21. Considered to be part of a vulnerable population (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRPCI patients; Patients undergoing non-emergent, high-risk percutaneous coronary interventions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.	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.	From device delivery through device removal (up to 4 hours).
Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal.	MDRAEs related to the device.	From device delivery through device removal (up to 4 hours).

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Supira Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: High-risk percutaneous coronary intervention; Supira System; Peripheral ventricular assist device
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Heart Failure; Heart Diseases; Coronary Artery Disease
• Other Study ID Numbers: CP-10002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No