Supira System for Heart Failure Patients

Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure

Recruiting N/A Interventional Study
Heart Disease Coronary Arterial Disease (CAD) Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 90
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Supira Medical · Industry
Who this trial is looking for

This trial is looking for patients with heart failure who have low heart function and need extra support during a heart procedure. Participants will be assessed for their safety and eligibility to use the Supira System.

Are You a Good Fit for This Trial?
Rules you out Severe liver diseaseAortic valve diseaseAortic stenosis

You may be able to join if

  • I have heart failure and my heart function is low.
  • I have a disease affecting my left main coronary artery or my other coronary arteries.
  • I might need extra support during the heart procedure.
  • I can provide my consent or have someone to consent for me.

You may not be able to join if

  • I had a stroke in the past 6 months.
  • I have moderate or severe aortic valve disease.
  • I have liver disease that is not well controlled.
  • I am on dialysis or need ongoing kidney treatment.
  • I have had issues with low blood platelets related to heparin.
  • I am allergic to certain contrast agents or heparin.
  • I am breastfeeding or pregnant.
  • I am participating in another clinical study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45% * Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disea…
Contacts

Clinical

clinical@supiramedical.com

CONTACT