Using the Supira percutaneous ventricular assist device during and after high-risk PCI

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

This study will try the Supira percutaneous ventricular assist device to give extra heart support during and after high-risk PCI for patients with heart failure and reduced ejection fraction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Supira Medical (industry)
• Locations: 2 sites (Tbilisi, K'alak'i T'bilisi and 1 other locations)
• Trial ID: NCT07407816 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, single-arm, multi-center feasibility trial of the Supira percutaneous ventricular assist device (pVAD) in patients with heart failure and LVEF ≤45% undergoing high-risk percutaneous coronary intervention (HRPCI). The device is inserted across the aortic valve into the left ventricle and unloads the ventricle by pumping blood into the ascending aorta to maintain systemic perfusion. The study will collect safety, device performance, and short-term clinical outcome data to determine if extended hemodynamic support beyond the index PCI is feasible. Enrollment focuses on patients with unprotected left main disease, last patent vessel, or three-vessel disease who may benefit from continued circulatory support.

Who should consider this trial

Good fit: Ideal candidates are adults with pre-existing heart failure (NYHA II–IV) and documented LVEF ≤45% who are planned for HRPCI (unprotected left main, last patent vessel, or three-vessel disease) and may benefit from support beyond the procedure who can give informed consent.

Not a fit: Patients with moderate-or-worse aortic valve disease, recent stroke, severe liver dysfunction, or ongoing dialysis are excluded and unlikely to benefit from this device in the context of this trial.

Why it matters

Potential benefit: If successful, the Supira device could reduce hemodynamic complications and make high-risk PCI safer by providing extended ventricular unloading and circulatory support.

How similar studies have performed: Other percutaneous ventricular assist devices such as Impella and TandemHeart have been used to provide hemodynamic support during HRPCI with demonstrated hemodynamic improvement, though clinical outcome benefits have been mixed and this specific device is being tested as a novel option.

Eligibility criteria

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

Where this trial is running

Tbilisi, K'alak'i T'bilisi and 1 other locations

• Tbilisi Heart and Vascular Clinic — Tbilisi, K'alak'i T'bilisi, Georgia (RECRUITING)
• Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia — Tbilisi, Georgia (RECRUITING)

Study contacts

• Study coordinator: Clinical

Conditions: Heart Disease, Coronary Arterial Disease, Heart Failure, Percutanous ventricular assist device, Supira System