Feasibility Study SA of the Supira System for HRPCI

NCT05864248 | Active Not Recruiting

• 1 other identifier: CP-10002
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

High-risk percutaneous coronary intervention; Peripheral ventricular assist device; Supira System

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Rate of Technical Success.

  From device delivery through device removal (up to 4 hours).

• Rate of Procedural Success

  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.

  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.

  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).

  From 30 days to 90 days post device removal.

Study Arms (1)

HRPCI patients

EXPERIMENTAL

Patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Device: Supira System

Interventions

Supira System DEVICE

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.

HRPCI patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
• Evidence of left ventricular thrombus
• Moderate or greater aortic valvular disease or regurgitation (≥ 2+ on a 4-grade scale as assessed on transthoracic echo cardiogram (TTE)
• Moderate or greater aortic stenosis (gradient \>20 mmHg or valve area \< 1.5 cm\^2 as assessed on TTE)
• Previous aortic valve replacement or reconstruction
• Ascending or descending aortic dissection or aortic aneurysm \> 4.5 cm
• Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device
• Presence of decompensated liver disease; severe liver dysfunction (Child class C)
• Patients requiring renal replacement therapy with dialysis
• Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy
• Current or history of heparin-induced thrombocytopenia (HIT)
• Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors, or nitinol
• 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)
• Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure

Sponsors & Collaborators

• Supira Medical: lead

Study Sites (2)

Instituto Dante Pazzanese De Cardiologia (Dante)

São Paulo, 04012-909, Brazil

Location

'Instituto Do Coração de São Paulo (InCor)'

São Paulo, 5403-000, Brazil

Location

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Feasibility Study

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 18, 2023
• Study Start: September 13, 2023
• Primary Completion: April 30, 2025
• Study Completion: March 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)