AVERT Plus Post-Market Registry

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT02436642
• Lead Sponsor: Osprey Medical, Inc

Brief Summary

The devices used in this observational registry are the Osprey Medical Contrast Monitoring System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark designations. The purpose of this registry is to evaluate the usability characteristics of the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal clinical use.

Detailed Description

This is a prospective, single-center, non-randomized, single arm, observational registry of the AVERT System used in combination with the Contrast Monitoring System. Patients undergoing manual manifold injection coronary artery imaging for diagnostic or PCI procedures that utilize the AVERT System and the CMS will be included in this registry. Device use characteristics including, measurement of contrast media volume used, contrast media volume saved by the use of the AVERT System, evaluation of angiographic image quality, and physician feedback on device features and function will be obtained. All data will be collected on the day of the procedure and there will be no long-term follow-up.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and CMS according to the labeled indications for these devices.
• Patient consent to participate

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast media volume usage	Day of procedure	Compare cumulative contrast media volume usage as displayed by the CMS to volume estimation commonly performed in the catheterization laboratory

Secondary Outcome Measures

Name	Time	Method
Physician feedback on device features	Day of procedure
Contrast media volume savings	Day of procedure	Use the displayed volume savings function of the Contrast Monitoring System to determine the percent reduction in contrast media delivered to the patient due to the use of the AVERT System.
Angiographic image quality	Day of procedure

Trial Locations

Locations (1)

Universitatsklinikum Schleswig-Holstein (Campus Lubeck); 🇩🇪 Lubeck, Germany