A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study

Not Applicable

Not yet recruiting

• Conditions: Ventricular Assist Device
• Interventions: Device: Supira System

• Registration Number: NCT06565039
• Lead Sponsor: Supira Medical

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Study Start: 2025-01
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Age ≥18 years and ≤90 years
2. Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary 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 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 IABP or any other circulatory support device at time of screening.
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 Transthoracic Echocardiogram (TTE)
4. Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE)
5. Aortic valve 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 repair
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 active systemic infection requiring ongoing antibiotic therapy
12. Heparin-induced thrombocytopenia, 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 International Normalized Ratio (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 prior or post index procedure
17. Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
18. 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
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 would have them be considered in any way to be part of a vulnerable population. This includes individuals who may have difficulty providing informed consent or are at a higher risk of coercion or undue influence, individuals permanently incapable of giving informed consent, and individuals whose ability to comply with study procedures may be compromised, in the opinion of the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supira System	Supira System	Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions.

Primary Outcome Measures

Name	Time	Method
Successful initiation and maintenance of hemodynamic support	90 days from procedure	A composite endpoint of safety and effectiveness outcomes, evaluated at 90 days, comprises the following outcomes: * All-cause death; * Myocardial infarction (MI); * Stroke or transient ischemic attack (TIA); * Unplanned repeat revascularization; * Major bleeding (BARC ³ 3); * Major vascular complications (MCS-ARC defined); * Sustained hypotension during mechanical circulatory support

Secondary Outcome Measures

Name	Time	Method
Procedural Success	90 days from procedure	Freedom from: 1. Major bleeding (BARC ³ 3); 2. Major vascular complications (MCS-ARC defined); 3. Sustained hypotension during mechanical circulatory support; 4. Need for mechanical circulatory support beyond the index procedure