Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) (SUPPORT II)

Supira Medical

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Mechanical Circulatory Support; Interventional Cardiology; High Risk Percutaneous Coronary Intervention

Treatments: Device: The Supira System; Device: Impella

Study type: Interventional

Funder types: Industry

Identifiers

NCT07296744

CP-10004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 358 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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
• 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
• 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
• Considered to be part of a vulnerable population per the investigator's assessment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

Supira System

Experimental group

Description:

Subjects receiving the Supira System

Treatment:

Device: The Supira System

Impella

Active Comparator group

Description:

Subjects receiving the Impella

Treatment:

Device: Impella