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

NCT07407816 | Recruiting

• 1 other identifier: CP-10005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Disease; Heart Failure; Coronary Arterial Disease (CAD)

Keywords

Percutanous ventricular assist device; Supira System

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Study Endpoints

  30 days

Study Arms (1)

HRPCI with low LVEF and severe CAD

EXPERIMENTAL

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

Interventions

Supira System DEVICE

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.

HRPCI with low LVEF and severe CAD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supira Medical: lead

Study Sites (2)

Tbilisi Heart and Vascular Clinic

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

RECRUITING

Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia

Tbilisi, Georgia

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Clinical

  Supira Medical

  STUDY DIRECTOR

Central Study Contacts

Clinical

CONTACT

clinical@supiramedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Feasibility Study

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 12, 2026
• Study Start: October 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2)