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Evaluation of workflow improvements of new software solution to be used during coronary interventions

Evaluation of workflow improvements of new software solution to be used during coronary interventions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25377
Enrollment
90
Registered
2015-06-25
Start date
2015-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Interventions

The patient will undergo standard of care medical treatment for his or her cardiac condition. During the procedure, the physician may make angiograms for diagnosis and as reference for device navigati

Sponsors

Philips Medical Systems Nederland B.V.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Subject will be undergoing a percutaneous coronary angiography or intervention -Subject is 18 years of age or older, or of legal age to give informed consent per national law

Exclusion criteria

Exclusion criteria: -Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips. -Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman).

Design outcomes

Primary

MeasureTime frame
Qualitative feedback of the use of the study device in order to establish an optimized workflow and usability.

Secondary

MeasureTime frame
Image data, adverse events, adverse device effects and device deficiencies that could have led to a serious adverse event.

Contacts

Public ContactRoland Bullens

Veenpluis 6

roland.bullens@philips.comTelephone: +31 610464132

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)