AVERT Plus Post-Market Registry

Coronary Artery Disease Clinical Trial

Official title:

AVERT Plus Post-Market Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02436642
• Other study ID #: TP-6432
• Status: Terminated
• Phase: N/A
• First received: May 4, 2015
• Last updated: May 18, 2016
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: Osprey Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• AVERT Plus System

Locations

Country	Name	City	State
Germany	Universitatsklinikum Schleswig-Holstein (Campus Lubeck)	Lubeck

Sponsors (1)

Lead Sponsor	Collaborator
Osprey Medical, Inc

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast media volume usage	Compare cumulative contrast media volume usage as displayed by the CMS to volume estimation commonly performed in the catheterization laboratory	Day of procedure	No
Secondary	Contrast media volume savings	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	No
Secondary	Angiographic image quality		Day of procedure	No
Secondary	Physician feedback on device features		Day of procedure	No