SUPPORT1: Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

• Sponsor: Supira Medical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06087575
• Collaborator: (none)
• Enrollment: 15
• Arm: 1
• Anticipated Duration (Months): 7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ventricular Assist Device	Device: Supira System	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The study is a prospective, non-randomized, single-arm, multicenter, feasibility studyThe study is a prospective, non-randomized, single-arm, multicenter, feasibility study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Supira System Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions.

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility - Successful initiation and maintenance of hemodynamic support [From device delivery through device removal (up to 4 hours)]

   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.

2. Safety - Rate of composite major device-related adverse events (MDRAE) [From device delivery through device removal (up to 4 hours)]

   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.

Secondary Outcome Measures

1. Technical Success [From device delivery through device removal (up to 4 hours)]

   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

2. Procedural Success [From device delivery through device removal (up to 4 hours)]

   Rate of procedural success, defined as the rate of technical success without procedural serious adverse events (SAEs)

3. Composite major MDRAE [From discharge through 30 days post device removal]

   Rate of composite major device-related adverse events (MDRAE) from device removal through hospital discharge

4. Composite MDRAE [From discharge through 30 days post device removal]

   Rate of composite MDRAE from hospital discharge through 30 days post device removal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Supira Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Supira Medical
• ClinicalTrials.gov Identifier: NCT06087575
• Other Study ID Numbers: CP-10003
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Oct 18, 2023