AVERT Plus Post-Market Registry

May 18, 2016 updated by: Osprey Medical, Inc

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.

Study Overview

Status

Terminated

Conditions

Coronary Artery Disease

Intervention / Treatment

Device: AVERT Plus System

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

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

Study Locations

Germany
- - Lubeck, Germany, 23538
    - Universitatsklinikum Schleswig-Holstein (Campus Lubeck)

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
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be included if they are scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and Contrast Monitoring System according to the labeled indications for these devices.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast media volume usage Time Frame: Day of procedure	Compare cumulative contrast media volume usage as displayed by the CMS to volume estimation commonly performed in the catheterization laboratory	Day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast media volume savings Time Frame: 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.	Day of procedure
Angiographic image quality Time Frame: Day of procedure		Day of procedure
Physician feedback on device features Time Frame: Day of procedure		Day of procedure

Collaborators and Investigators

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

Sponsor

Osprey Medical, Inc

Investigators

Principal Investigator: Steffen Desch, MD, Universitatsklinikum Schleswig-Holstein (Campus Lubeck)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kaye DM, Stub D, Mak V, Doan T, Duffy SJ. Reducing iodinated contrast volume by manipulating injection pressure during coronary angiography. Catheter Cardiovasc Interv. 2014 Apr 1;83(5):741-5. doi: 10.1002/ccd.25348. Epub 2014 Jan 7.

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

May 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)