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 range

18 Years – 90 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 90 Years

Sex

ALL

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

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).