AVERT Plus Post-Market Registry

NCT02436642 | Terminated

• 1 other identifier: TP-6432
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Contrast media volume savings

  Day of procedure

• Angiographic image quality

  Day of procedure

• Physician feedback on device features

  Day of procedure

Interventions

AVERT Plus System DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Osprey Medical, Inc: lead

Study Sites (1)

Universitatsklinikum Schleswig-Holstein (Campus Lubeck)

Lübeck, 23538, Germany

Location

Related 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.

  PMID: 24323791 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Steffen Desch, MD

  Universitatsklinikum Schleswig-Holstein (Campus Lubeck)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)