Early Feasibility Study of the Supira System in Patients Undergoing HRPCI (SUPPORT1)

Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; High-risk Percutaneous Coronary Intervention; Interventional Cardiology
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis (UC Davis) Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute Cardiovascular Research
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center Cardiology Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supira System; Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions.

Device: Supira 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Successful initiation and maintenance of hemodynamic support	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.	From device delivery through removal (up to 4 hours)
Safety: Rate of composite major device-related adverse events (MDRAEs), from device insertion through device removal (inclusive of Supira procedure-related SAEs).	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.	From device delivery through device removal (up to 4 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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	From device delivery through device removal (up to 4 hours)
Procedural Success	Rate of procedural success, defined as the rate of technical success without procedural SAEs.	From device delivery through device removal (up to 4 hours)
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.
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.
Rate of composite MDRAEs from 30 days to 90 days post device removal.		From 30 days to 90 days post device removal.

Collaborators and Investigators

• Sponsor: Supira Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Actual): February 25, 2025
• Study Completion (Actual): April 17, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: left ventricular assist device (LVAD); Supira System; peripheral mechanical circulatory support (MCS)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CP-10003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No