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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: clinical@supiramedical.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.