Clinical Trial

Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

Study acronym: SUPPORT II
Recruiting
View on ClinicalTrials.gov →
Summary
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
Protocol Amendment History 7 changes
notable Trial sites expanded: 14 -> 19 locations 2026-07-09
notable Trial sites expanded: 11 -> 14 locations 2026-06-12
critical Recruitment opened 2026-05-30
notable Trial sites expanded: 7 -> 11 locations 2026-05-30
notable Primary completion pushed: 2027-04 -> 2027-11 2026-05-30
minor Completion pushed: 2027-07 -> 2027-11 2026-05-30
notable Trial sites expanded: 0 -> 7 locations 2026-04-14
Trial Details
NCT Number NCT07296744
Lead Sponsor Supira Medical
Conditions Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
Enrollment 358 participants
Start Date 2026-05-11
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-08