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

ConditionsHeart DiseaseCoronary Arterial Disease (CAD)Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSupira Medical

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 disease

Subject may benefit from hemodynamic support beyond the index procedure

Informed consent granted by the patient or legally authorized representative

Disqualifiers

Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit

Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)

Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)

Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)

Trial design

Design model

Single group

Treatments tested in this trial

  • Supira System

    Device

    The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI). The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: HRPCI with low LVEF and severe CADExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety

Rate of major device-related adverse events (MDRAEs), from device (Supira Introducer sheath) insertion through device removal (inclusive of Supira procedure-related serious adverse events \[SAEs\]).

Time frame
Perioperative/Periprocedural
2

Feasibility:

Successful hemodynamic support using the Supira System during high-risk percutaneous coronary intervention (HRPCI) and post-PCI as needed, with planned removal of the Supira Pump without the need to escalate/exchange to another MCS device such as Intra-aortic Balloon Pump (IABP) or Extracorporeal Membrane Oxygenation (ECMO).

Time frame
Perioperative/Periprocedural

Secondary outcomes

1

Secondary Study Endpoints

* Rate of technical success * Rate of procedural success * Rate of composite MDRAEs from cath lab discharge to Supira Catheter removal * Rate of composite MDRAEs from Supira Catheter removal to hospital discharge * Rate of MDRAEs from hospital discharge to 30 days

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Supira Medical

Lead sponsor

Source ClinicalTrials.gov
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