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NCT05864248 | Not yet recruiting | Heart Diseases

Feasibility Study SA of the Supira System for HRPCI
Sponsor:

Supira Medical

Brief Summary:

The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.

Condition or disease

Heart Diseases

Heart Failure

Intervention/treatment

Supira System

Phase

Not Applicable

Detailed Description:

The Feasibility Study SA is planned as a prospective, single-arm, interventional multi-center study enrolling up to 30 subjects. The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta. The Supira System is a temporary ventricular support device indicated for use for a short time during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.}}

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Feasibility Study SA of the Supira System for HRPCI
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : February 28, 2024
Arm Intervention/treatment

Experimental: HRPCI patients

Patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Device: Supira System
Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Age ≥ 18 and ≤ 90 years
  • Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
  • Signed the informed consent
Exclusion Criteria
  • ST-elevation myocardial infarction (STEMI) within 30 days
  • Stroke within 3 months of the index procedure, or prior stroke > 3 months with any permanent neurologic deficit
  • Evidence of left ventricular thrombus
  • Previous aortic valve replacement or reconstruction
  • Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm
  • Previous transcatheter mitral valve replacement or repair
  • Ventricular septal defect
  • Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device
  • Mechanical ventilation due to primary respiratory mechanical dysfunction (e.g., pneumonia, ARDS, pneumothorax)
  • Breastfeeding or pregnant
  • Currently participating in active follow-up phase of another clinical study of an investigational drug or device
  • Active COVID-related infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  • Considered to be part of a vulnerable population
  • Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)
Feasibility Study SA of the Supira System for HRPCI

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Feasibility Study SA of the Supira System for HRPCI

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