Feasibility Study SA of the Supira System for HRPCI

Sponsor

Supira Medical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05864248

Collaborator

(none)

Enrollment

Arm

8.9

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Heart Diseases Heart Failure	Device: Supira System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility Study SA of the Supira System for HRPCI

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Supira System Technical Success [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.
Rate of procedural success [From device delivery through device removal (up to 6 hours)]
Rate of technical success without procedural serious adverse events (SAEs).
Rate of composite MDRAE [From discharge through 30 days]
Rate of composite MDRAE
Rate of each individual MDRAE [From time of initiation of index procedure through 30 days]
Rate of each individual MDRAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Supira Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Supira Medical

ClinicalTrials.gov Identifier:

NCT05864248

Other Study ID Numbers:

CP-10002

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Supira Medical

Supira

HRPCI

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of May 18, 2023