Coronary Artery Disease
Conditions
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.
Interventions
DEVICEAVERT Plus System
Sponsors
Osprey Medical, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Physician feedback on device features | Day of procedure | — |
Countries
Germany
Outcome results
None listed