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

NCT06565039 | Withdrawn DMC FDA Device

• 1 other identifier: CP-10006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Successful initiation and maintenance of hemodynamic support

  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

  90 days from procedure

Secondary Outcomes (1)

• Procedural Success

  90 days from procedure

Study Arms (1)

Supira System

EXPERIMENTAL

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

Device: Supira System

Interventions

Supira System DEVICE

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.

Supira System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤90 years
• Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary as determined by the institutional Heart Team.
• Informed consent granted by the patient or legally authorized representative

You may not qualify if:

• 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.
• 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 valve stenosis categorized as moderate or greater (gradient \>20 mmHg or valve area \<1.5 cm2 as assessed on TTE)
• Previous aortic valve replacement or repair
• 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 active systemic 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

Sponsors & Collaborators

• Supira Medical: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, non-randomized, single-arm, multicenter study

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share