Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

Ventricular Assist Device Clinical Trial

— SUPPORT1  

Official title:

Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06087575
• Other study ID #: CP-10003
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Supira Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 be used to support subsequent regulatory applications and further evaluation of the Supira System.

Description:

The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.

Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =90 years

2. Presents with hemodynamic stability and need for elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team

3. Informed consent granted by the patient or legally authorized representative

Exclusion Criteria:

1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure

2. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit

3. Evidence of left ventricular thrombus as assessed by TTE

4. Aortic valvular disease or regurgitation categorized as moderate or greater (= 2+ on a 4-grade scale as assessed on TTE)

5. Aortic stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)

6. Previous aortic valve replacement or reconstruction

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

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

9. Presence of decompensated liver disease; severe liver dysfunction (Child class C)

10. Ongoing renal replacement therapy with dialysis

11. Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy

12. Heparin-induced thrombocytopenia (HIT), current or any prior occurrences

13. 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

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)

15. Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure

16. Planned coronary intervention within 30 days post index procedure

17. Breastfeeding or pregnant

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

19. Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments

20. 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

21. Considered to be part of a vulnerable population

Related Conditions & MeSH terms

• Ventricular Assist Device

Intervention

Device:
• Supira System
The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist (pVAD) system that is intended to provide temporary (=4 hours) hemodynamic support to patients undergoing a high-risk percutaneous coronary intervention (HRPCI). The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Supira Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Successful initiation and maintenance of hemodynamic support	Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure. Severe hypotension is defined as sustained mean arterial pressure (MAP) < 55 mmHg requiring inotropic/pressor medications and/or alternative mechanical circulatory support.	From device delivery through device removal (up to 4 hours)
Primary	Safety - Rate of composite major device-related adverse events (MDRAE)	Rate of composite major device-related adverse events (MDRAE), device delivery through device removal. MDRAEs are defined as any events that are adjudicated by the CEC as definitely, possibly, or probably related to the Supira System.	From device delivery through device removal (up to 4 hours)
Secondary	Technical Success	Rate of technical success, defined as completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful removal of the Catheter	From device delivery through device removal (up to 4 hours)
Secondary	Procedural Success	Rate of procedural success, defined as the rate of technical success without procedural serious adverse events (SAEs)	From device delivery through device removal (up to 4 hours)
Secondary	Composite major MDRAE	Rate of composite major device-related adverse events (MDRAE) from device removal through hospital discharge	From discharge through 30 days post device removal
Secondary	Composite MDRAE	Rate of composite MDRAE from hospital discharge through 30 days post device removal	From discharge through 30 days post device removal