Status:
ACTIVE_NOT_RECRUITING
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI
Lead Sponsor:
Supira Medical
Conditions:
Coronary Artery Disease
High-risk Percutaneous Coronary Intervention
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. The clinical data may b...
Detailed Description
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 disea...
Eligibility Criteria
Inclusion
- Subjects will be eligible for inclusion in this study if all of the following criteria apply:
- Age ≥18 and ≤90 years
- Subject is hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team
- Informed consent granted by the patient or legally authorized representative
- Subjects who meet any one of the following criteria will be excluded from study participation:
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- a. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure (BP) \<90 mmHg or the need for inotropes/pressors to maintain a systolic BP \>90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of intra-aortic balloon pump (IABP), or any other circulatory support device.
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
- Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
- Aortic stenosis categorized as moderate or greater (gradient \>20 mmHg or valve area \<1.5 cm\^2 as assessed on TTE)
- Previous aortic valve replacement or reconstruction
- Ascending or descending aortic dissection or aortic aneurysm \>4.5 cm
- Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device
- Presence of decompensated liver disease; severe liver dysfunction (Child class C)
- Ongoing renal replacement therapy with dialysis
- Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic 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 or known fibrinogen ≤1.5 g/L)
- Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- Planned coronary intervention within 30 days post index procedure
- Breastfeeding or pregnant
- Currently participating in active follow-up phase of another clinical study of an investigational drug or device
- Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments
- 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 (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
Exclusion
Key Trial Info
Start Date :
October 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06087575
Start Date
October 4 2024
End Date
June 30 2025
Last Update
May 16 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis (UC Davis) Medical Center
Sacramento, California, United States, 95817
2
Piedmont Heart Institute Cardiovascular Research
Atlanta, Georgia, United States, 30309
3
Mount Sinai
New York, New York, United States, 10029
4
Montefiore Medical Center Cardiology Research
The Bronx, New York, United States, 10467