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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Georgia
Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia
RECRUITING
Tbilisi
Tbilisi Heart and Vascular Clinic
RECRUITING
Tbilisi
Contact Information
Primary
Clinical
clinical@supiramedical.com
Time Frame
Start Date: 2025-10-12
Estimated Completion Date: 2027-05
Participants
Target number of participants: 45
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Supira Medical