Active — Not RecruitingNot Applicable

Feasibility Study SA of the Supira System for HRPCI

Brazil71 participantsStarted 2023-09-13

Plain-language summary

The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 and ≤ 90 years
✓. Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
✓. Signed the informed consent

Exclusion criteria

✕. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic 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 intra-aortic balloon pump (IABP), or any other circulatory support device.
✕. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
✕. Evidence of left ventricular thrombus
✕. Moderate or greater aortic valvular disease or regurgitation (≥ 2+ on a 4-grade scale as assessed on transthoracic echo cardiogram (TTE)
✕. Moderate or greater aortic stenosis (gradient \>20 mmHg or valve area \< 1.5 cm\^2 as assessed on TTE)
✕. Previous aortic valve replacement or reconstruction
✕. Ascending or descending aortic dissection or aortic aneurysm \> 4.5 cm
✕. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device

What they're measuring

Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.

Timeframe: From device delivery through device removal (up to 4 hours).

Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal.

Timeframe: From device delivery through device removal (up to 4 hours).

Trial details

NCT IDNCT05864248

SponsorSupira Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Heart Diseases trials

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 and ≤ 90 years
✓. Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
✓. Signed the informed consent

Exclusion criteria

✕. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic 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 intra-aortic balloon pump (IABP), or any other circulatory support device.
✕. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
✕. Evidence of left ventricular thrombus
✕. Moderate or greater aortic valvular disease or regurgitation (≥ 2+ on a 4-grade scale as assessed on transthoracic echo cardiogram (TTE)
✕. Moderate or greater aortic stenosis (gradient \>20 mmHg or valve area \< 1.5 cm\^2 as assessed on TTE)
✕. Previous aortic valve replacement or reconstruction
✕. Ascending or descending aortic dissection or aortic aneurysm \> 4.5 cm
✕. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device

What they're measuring

Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.

Timeframe: From device delivery through device removal (up to 4 hours).

Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal.

Timeframe: From device delivery through device removal (up to 4 hours).