Ventricular Assist Device
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
Detailed description
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, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option. Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events
Interventions
DEVICESupira System
The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a high-risk percutaneous coronary intervention (HRPCI). 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
TREATMENT
Masking
NONE
Intervention model description
The study is a prospective, non-randomized, single-arm, multicenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤90 years 2. Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary as determined by the institutional Heart Team. 3. Informed consent granted by the patient or legally authorized representative
Exclusion criteria
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 IABP or any other circulatory support device at time of screening. 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 valve stenosis categorized as moderate or greater (gradient \>20 mmHg or valve area \<1.5 cm2 as assessed on TTE) 6. Previous aortic valve replacement or repair 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 active systemic 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 prior or post index procedure 17. Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure 18. Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure 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 would have them be considered in any way to be part of a vulnerable population. This includes individuals who may have difficulty providing informed consent or are at a higher risk of coercion or undue influence, individuals permanently incapable of giving informed consent, and individuals whose ability to comply with study procedures may be compromised, in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful initiation and maintenance of hemodynamic support | 90 days from procedure | A composite endpoint of safety and effectiveness outcomes, evaluated at 90 days, comprises the following outcomes: * All-cause death * Myocardial infarction (MI) * Stroke or transient ischemic attack (TIA) * Unplanned repeat revascularization * Major bleeding (BARC ³ 3) * Major vascular complications (MCS-ARC defined) * Sustained hypotension during mechanical circulatory support |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 90 days from procedure | Freedom from: 1. Major bleeding (BARC ³ 3) 2. Major vascular complications (MCS-ARC defined) 3. Sustained hypotension during mechanical circulatory support 4. Need for mechanical circulatory support beyond the index procedure |
Outcome results
None listed