Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure

Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure

The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Disease; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Device: Supira System

Detailed Description

The study is a prospective, non-randomized, single-arm, multi-center, feasibility study.

The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI) and requiring hemodynamic support. The Catheter is inserted percutaneously, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical; Email: clinical@supiramedical.com

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia
    • Contact: Eter Bekaia; Phone Number: + 995 32 243 33 43; Email: annabekaia@gmail.com
  • K'alak'i T'bilisi
    • Tbilisi, K'alak'i T'bilisi, Georgia, 0112
      • Recruiting
      • Tbilisi Heart and Vascular Clinic
      • Contact: Elene Khabeishvili, MD; Phone Number: +995 32 218 15 55; Email: Elenekhabeishvili@outlook.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
• Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease
• Subject may benefit from hemodynamic support beyond the index procedure
• Informed consent granted by the patient or legally authorized representative

Exclusion Criteria:

• Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
• Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
• Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
• Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
• Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
• Heparin-induced thrombocytopenia, current or any prior occurrences
• 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
• Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g/L)
• Breastfeeding or pregnant
• Currently participating in active follow-up phase of another clinical study of an investigational drug or device
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: HRPCI with low LVEF and severe CAD; Patients undergoing HRPCI with low LVEF and severe coronary artery disease who may benefit from cardiovascular hemodynamic support beyond the PCI procedure

Device: Supira System; The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing 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. 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
Safety	Rate of major device-related adverse events (MDRAEs), from device (Supira Introducer sheath) insertion through device removal (inclusive of Supira procedure-related serious adverse events [SAEs]).	Perioperative/Periprocedural
Feasibility:	Successful hemodynamic support using the Supira System during high-risk percutaneous coronary intervention (HRPCI) and post-PCI as needed, with planned removal of the Supira Pump without the need to escalate/exchange to another MCS device such as Intra-aortic Balloon Pump (IABP) or Extracorporeal Membrane Oxygenation (ECMO).	Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Study Endpoints	Rate of technical success; Rate of procedural success; Rate of composite MDRAEs from cath lab discharge to Supira Catheter removal; Rate of composite MDRAEs from Supira Catheter removal to hospital discharge; Rate of MDRAEs from hospital discharge to 30 days	30 days

Collaborators and Investigators

• Sponsor: Supira Medical
• Investigators: Study Director: Clinical, Supira Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Supira System; Percutanous ventricular assist device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Failure; Heart Diseases
• Other Study ID Numbers: CP-10005

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: No