Coronary Artery Disease, High-risk Percutaneous Coronary Intervention, Interventional Cardiology
Conditions
Keywords
left ventricular assist device (LVAD), peripheral mechanical circulatory support (MCS), Supira System
Brief summary
The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. The clinical data may be used to support subsequent regulatory applications and further evaluation of the Supira System.
Detailed description
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.
Interventions
DEVICESupira System
The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist device (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a HRPCI procedure. The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
Sponsors
Supira Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The study is a prospective, non-randomized, single-arm, multicenter, feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible for inclusion in this study if all of the following criteria apply: 1. Age ≥18 and ≤90 years 2. Subject is hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team 3. Informed consent granted by the patient or legally authorized representative Subjects who meet any one of the following criteria will be excluded from study participation: 1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure a. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure (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 as assessed by Transthoracic Echocardiogram (TTE) 4. Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE) 5. Aortic stenosis categorized as moderate or greater (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 investigational device 9. Presence of decompensated liver disease; severe liver dysfunction (Child class C) 10. Ongoing renal replacement therapy with dialysis 11. Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy 12. Heparin-induced thrombocytopenia, current or any prior occurrences 13. Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol 14. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (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 prior COVID-19 diagnosis with sequelae that could confound endpoint assessments 20. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Successful initiation and maintenance of hemodynamic support | From device delivery through removal (up to 4 hours) | Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure. Sustained hypotension is defined as sustained mean arterial pressure (MAP) \< 60 mmHg requiring inotropic/pressor medications or alternative mechanical circulatory support. |
| Safety: Rate of composite major device-related adverse events (MDRAEs), from device insertion through device removal (inclusive of Supira procedure-related SAEs). | From device delivery through device removal (up to 4 hours) | MDRAEs are defined as any serious adverse events that are adjudicated by the Clinical Events Committee (CEC) as definitely or probably related to the Supira System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite MDRAEs from 30 days to 90 days post device removal. | From 30 days to 90 days post device removal. | — |
| Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever occurs first. | From device removal through hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal. | — |
| Procedural Success | From device delivery through device removal (up to 4 hours) | Rate of procedural success, defined as the rate of technical success without procedural SAEs. |
| Technical Success | From device delivery through device removal (up to 4 hours) | Rate of technical success, defined as completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful removal of the Catheter |
| Rate of composite MDRAEs 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) through 30 days post device removal. | — |
Countries
United States
Outcome results
None listed