Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSupira Medical
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Supira System
Treatment groups
45 Participants
are divided into 1 treatment groupLocations
2Tbilisi Heart and Vascular Clinic0112, TbilisiK'alak'i T'bilisi, Georgia
Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia Tbilisi Georgia
Sponsors and collaborators
Supira Medical
Lead sponsor
Source ClinicalTrials.gov