A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study (NCT06565039) | Clinical Trial Compass
WithdrawnNot Applicable
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
Stopped: Study was never submitted to any Ethics Committee, Competant Authorities or any regulatory body. It was decided to cancel the study and not to proceed.
0Started 2024-01
Plain-language summary
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during 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 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
Exclusion criteria
. 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)
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.
1This trial has been listed as 'Withdrawn' — can you tell me whether it was withdrawn due to safety concerns, funding issues, or something else, and how that affects my options for accessing the Supira system?
2Since this study was focused on high-risk percutaneous coronary intervention and using a ventricular assist device for hemodynamic support, can you help me understand whether I would even be considered a candidate for that type of procedure, and what the alternatives look like?
3The trial's main goal was measuring whether the Supira system could successfully start and maintain heart support during a procedure — since the study didn't complete, what do we actually know about how safe and effective this device is compared to other mechanical support options that have more published data?
4Are there other active clinical trials or approved devices for hemodynamic support during high-risk cardiac procedures that I should be looking into instead, given that this particular study is no longer enrolling?
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
1
Successful initiation and maintenance of hemodynamic support