Clinical trial NCT05864248: Feasibility Study SA of the Supira System for HRPCI
Official title: Feasibility Study SA of the Supira System for HRPCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Diseases
Coronary Artery Disease (CAD)
Heart Failure
Keywords: High-risk percutaneous coronary intervention
Peripheral ventricular assist device
Supira System
Lead sponsor: Supira Medical
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility Study
Primary purpose: DEVICE_FEASIBILITY

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

Eligibility criteria: 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)

Primary outcomes:
measure: Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.
timeFrame: From device delivery through device removal (up to 4 hours).
measure: Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal.
timeFrame: From device delivery through device removal (up to 4 hours).
Secondary outcomes:
measure: Rate of Technical Success.
timeFrame: From device delivery through device removal (up to 4 hours).
measure: Rate of Procedural Success
timeFrame: From device delivery through device removal (up to 4 hours).
measure: Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever comes first.
timeFrame: From device removal through hospital discharge or 72 hours post-procedure, whichever occurs first.
measure: Rate of composite MDRAE from hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.
timeFrame: From hospital discharge or 72 hours post-procedure (whichever occurs first)
measure: Rate of composite MDRAE from 30 days to 90 days post device removal (for subjects enrolled and treated after the first 30 subjects).
timeFrame: From 30 days to 90 days post device removal.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese De Cardiologia (Dante)
city: São Paulo
country: Brazil
facility: 'Instituto Do Coração de São Paulo (InCor)'
Study officials:
References: