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

Purpose

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).

Conditions

  • Coronary Artery Disease
  • High Risk Percutaneous Coronary Intervention
  • Interventional Cardiology
  • Mechanical Circulatory Support

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible 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 - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a prospective, multicenter, open label, randomized controlled trial (RCT). Subjects undergoing HRPCI will be randomized (1:1)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Supira System 		Subjects receiving the Supira System
  • Device: The Supira System
    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 has determined HRPCI is the appropriate therapeutic option.
Active Comparator
Impella 		Subjects receiving the Impella
  • Device: Impella
    The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i

Recruiting Locations

UC Davis
Sacramento, California 95817
Contact:
Garrett Wong, M.D.

Piedmont Heart Institute
Atlanta, Georgia 30309
Contact:
David Kandzari, M.D.

Henry Ford Health / St. John Hospital
Detroit, Michigan 48236
Contact:
Amir Kaki, M.D.

CentraCare
Saint Cloud, Minnesota 56362
Contact:
Stephen Kidd, M.D.

Montefiore Medical Center
The Bronx, New York 10467
Contact:
Andrea Mignatti, M.D.

Oklahoma Heart Hillcrest Medical
Tulsa, Oklahoma 74104
Contact:
Kamran Muhammad, M.D.

More Details

Status
Recruiting
Sponsor
Supira Medical

Study Contact

Supira Medical
(669) 330-0883
clinical@supiramedical.com

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.