No registrations found.
ID
Source
Health condition
Coronary Artery Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qualitative feedback of the use of the study device in order to establish an optimized workflow and usability.
Secondary outcome
Image data, adverse events, adverse device effects and device deficiencies that could have led to a serious adverse event.
Background summary
This evaluation investigates the workflow improvements of new software solutions to be used during coronary interventions. Qualitative feedback of the software usage will be collected in order to understand how well the software supports and improves the current percutaneous coronary intervention workflow. Also, patient demographics, procedure time, contrast usage and adverse events will be collected for comparison to historic data.
Study objective
This evaluation does not have a hypothesis to be tested since it is intended to evaluate the workflow and usability of the new software solution, without prior defined performance criteria.
Study design
The total duration of the study is expected to take approximately 9 months.
Intervention
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 navigation as part of the standard care. These angiograms will be automatically processed in the new software solution and displayed on fluoroscopy for navigation support. In case a balloon catheter is inserted into the coronary arteries, the physician may take cine images as part of the standard care. These images can be automatically enhanced in the new software solution. After the procedure is finished, the patient will leave the study.
Roland Bullens
Eindhoven 5684 PC
The Netherlands
Telephone: +31 610464132
roland.bullens@philips.com
Roland Bullens
Eindhoven 5684 PC
The Netherlands
Telephone: +31 610464132
roland.bullens@philips.com
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
-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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5092 |
| NTR-old | NTR5224 |
| Other | Ethikkommission der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf, Kinderklinik : XCY607-130094 |