Feasibility Study SA of the Supira System for HRPCI

Heart Failure Clinical Trial

Official title:

Feasibility Study SA of the Supira System for HRPCI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05864248
• Other study ID #: CP-10002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2023
• Source: Supira Medical
• Contact: Nicole Haratani
• Phone: (408) 560-2500
• Email: nicole[@]supiramedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.

Description:

The Feasibility Study SA is planned as a prospective, single-arm, interventional multi-center study enrolling up to 30 subjects. The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta. The Supira System is a temporary ventricular support device indicated for use for a short time during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 28, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age = 18 and = 90 years

2. Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team

3. Signed the informed consent

Exclusion Criteria:

1. ST-elevation myocardial infarction (STEMI) within 30 days

2. Stroke within 3 months of the index procedure, or prior stroke > 3 months with any permanent neurologic deficit

3. Evidence of left ventricular thrombus

4. Previous aortic valve replacement or reconstruction

5. Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm

6. Previous transcatheter mitral valve replacement or repair

7. Ventricular septal defect

8. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device

9. Mechanical ventilation due to primary respiratory mechanical dysfunction (e.g., pneumonia, ARDS, pneumothorax)

10. Breastfeeding or pregnant

11. Currently participating in active follow-up phase of another clinical study of an investigational drug or device

12. Active COVID-related infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

13. Considered to be part of a vulnerable population

14. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count = 100,000/mm³ or spontaneous INR = 1.5 or known fibrinogen = 1.5 g/L)

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure

Intervention

Device:
• Supira System
The Supira System is a temporary (= 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Supira Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major Device-Related Adverse Events (MDRAE)	The rate of Supira System related Serious Adverse Events	From device delivery through device removal (up to 6 hours)
Primary	Successful initiation and maintenance of hemodynamic support without Severe Hypotension	Rate of successful initiation and maintenance of Supira System hemodynamic support without Severe Hypotension	From device delivery through device removal (up to 6 hours)
Secondary	Rate of Supira System Technical Success	Completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful retrieval of the catheter.	From device delivery through device removal (up to 6 hours)
Secondary	Rate of procedural success	Rate of technical success without procedural serious adverse events (SAEs).	From device delivery through device removal (up to 6 hours)
Secondary	Rate of composite MDRAE	Rate of composite MDRAE	From discharge through 30 days
Secondary	Rate of each individual MDRAE	Rate of each individual MDRAE	From time of initiation of index procedure through 30 days