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Official title Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
ClinicalTrials.gov ID: NCT07296744
What this study is testing
- What it's testing
- The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the...
- Informed consent granted by the subject or legally authorized representative
You likely can't join if
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Left ventricular thrombus
- Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
- Ongoing renal replacement therapy with dialysis
- Presence of decompensated liver disease; severe liver dysfunction
See the full eligibility criteria
- 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 subject or legally authorized representative
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- Left ventricular thrombus
- Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
- Ongoing renal replacement therapy with dialysis
- Presence of decompensated liver disease; severe liver dysfunction
- Infection of the proposed procedural access site or active infection
- 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
- Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
- 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
- Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
- Considered to be part of a vulnerable population per the investigator's assessment
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Sacramento, California, United States
- Thousand Oaks, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Saint Cloud, Minnesota, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- York, Pennsylvania, United States
- Columbia, South Carolina, United States
- Plano, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Sacramento, California, United States; Thousand Oaks, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Detroit, Michigan, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.