Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
SUPPORT II
Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
1 other identifier
interventional
358
1 country
14
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started May 2026
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedStudy Start
First participant enrolled
May 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
June 11, 2026
June 1, 2026
1.5 years
December 18, 2025
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Safety and Efficacy Outcomes
* All-cause death * Myocardial infarction * Stroke or transient ischemic attack * Major bleeding * Major access site-related vascular complications * Acute Kidney Injury * Unplanned repeat revascularization * Sustained hypotensiona during mechanical circulatory support * Arrythmia requiring cardioversion during pump use
30 days
Secondary Outcomes (1)
Secondary Outcome Measures
30 and 90 days
Study Arms (2)
Supira System
EXPERIMENTALSubjects receiving the Supira System
Impella
ACTIVE COMPARATORSubjects receiving the Impella
Interventions
The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.
Eligibility Criteria
You may qualify if:
- Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team
- Informed consent granted by the subject or legally authorized representative
You may not qualify if:
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Left ventricular thrombus
- Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
- Ongoing renal replacement therapy with dialysis
- Presence of decompensated liver disease; severe liver dysfunction
- Infection of the proposed procedural access site or active infection
- 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
- Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
- Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure
- 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
- Considered to be part of a vulnerable population per the investigator's assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Supira Medicallead
Study Sites (14)
UC Davis
Sacramento, California, 95817, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Henry Ford Health / St. John Hospital
Detroit, Michigan, 48236, United States
CentraCare
Saint Cloud, Minnesota, 56362, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
University of Buffalo (Buffalo General)
Buffalo, New York, 14203, United States
Cuimc/Nyph
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
OhioHealth
Columbus, Ohio, 43214, United States
Oklahoma Heart Hillcrest Medical
Tulsa, Oklahoma, 74104, United States
Wellspan York Hospital
York, Pennsylvania, 17403, United States
Prisma Health
Columbia, South Carolina, 29203, United States
Baylor Scott & White The Heart Hospital
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
December 22, 2025
Study Start
May 11, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share