Supira System in high-risk PCI: a pivotal comparison to Impella

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, controlled comparison of the Supira System versus the Impella for temporary left-ventricular support during high-risk percutaneous coronary intervention. Eligible patients are adults undergoing elective or urgent HRPCI who need hemodynamic support and meet predefined criteria. The Supira System is a percutaneous ventricular assist device delivered through the femoral artery to unload the left ventricle for up to 4 hours during the procedure. Outcomes focus on safety and efficacy of hemodynamic support and device performance. The study is conducted at three California centers and is sponsored by Supira Medical.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Loma Linda University Medical Center
  Loma Linda, California, United States Recruiting
• UC Davis
  Sacramento, California, United States Recruiting
• Los Robles Regional Medical Center
  Thousand Oaks, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Supira Medical
• Email: clinical@supiramedical.com
• Phone: (669) 330-0883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.