Feasibility Study SA of the Supira System for HRPCI

May 8, 2023 updated by: Supira Medical
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 90 years
  2. Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
  3. Signed the informed consent

Exclusion Criteria:

  1. ST-elevation myocardial infarction (STEMI) within 30 days
  2. Stroke within 3 months of the index procedure, or prior stroke > 3 months with any permanent neurologic deficit
  3. Evidence of left ventricular thrombus
  4. Previous aortic valve replacement or reconstruction
  5. Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm
  6. Previous transcatheter mitral valve replacement or repair
  7. Ventricular septal defect
  8. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device
  9. Mechanical ventilation due to primary respiratory mechanical dysfunction (e.g., pneumonia, ARDS, pneumothorax)
  10. Breastfeeding or pregnant
  11. Currently participating in active follow-up phase of another clinical study of an investigational drug or device
  12. Active COVID-related infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  13. Considered to be part of a vulnerable population
  14. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRPCI patients
Patients undergoing non-emergent, high-risk percutaneous coronary interventions.
Device: Supira System
The Supira System is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Device-Related Adverse Events (MDRAE)
Time Frame: From device delivery through device removal (up to 6 hours)
The rate of Supira System related Serious Adverse Events
From device delivery through device removal (up to 6 hours)
Successful initiation and maintenance of hemodynamic support without Severe Hypotension
Time Frame: From device delivery through device removal (up to 6 hours)
Rate of successful initiation and maintenance of Supira System hemodynamic support without Severe Hypotension
From device delivery through device removal (up to 6 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Supira System Technical Success
Time Frame: From device delivery through device removal (up to 6 hours)
Completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful retrieval of the catheter.
From device delivery through device removal (up to 6 hours)
Rate of procedural success
Time Frame: From device delivery through device removal (up to 6 hours)
Rate of technical success without procedural serious adverse events (SAEs).
From device delivery through device removal (up to 6 hours)
Rate of composite MDRAE
Time Frame: From discharge through 30 days
Rate of composite MDRAE
From discharge through 30 days
Rate of each individual MDRAE
Time Frame: From time of initiation of index procedure through 30 days
Rate of each individual MDRAE
From time of initiation of index procedure through 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supira Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-10002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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