Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Supira Medical
- Enrollment
- 358
- Locations
- 7
- Primary Endpoint
- Composite Safety and Efficacy Outcomes
Overview
Brief Summary
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
Detailed Description
The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team
- •Informed consent granted by the subject or legally authorized representative
Exclusion Criteria
- •Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- •Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- •Left ventricular thrombus
- •Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
- •Ongoing renal replacement therapy with dialysis
- •Presence of decompensated liver disease; severe liver dysfunction
- •Infection of the proposed procedural access site or active infection
- •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
- •Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- •Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
Arms & Interventions
Supira System
Subjects receiving the Supira System
Intervention: The Supira System (Device)
Impella
Subjects receiving the Impella
Intervention: Impella (Device)
Outcomes
Primary Outcomes
Composite Safety and Efficacy Outcomes
Time Frame: 30 days
* All-cause death * Myocardial infarction * Stroke or transient ischemic attack * Major bleeding * Major access site-related vascular complications * Acute Kidney Injury * Unplanned repeat revascularization * Sustained hypotensiona during mechanical circulatory support * Arrythmia requiring cardioversion during pump use
Secondary Outcomes
- Secondary Outcome Measures(30 and 90 days)