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van CCT (UK)


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van CCT (UK)


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


- candidate number22386
- NTR NumberNTR5224
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2015
- Secondary IDsXCY607-130094 
- Public TitleEvaluation of workflow improvements of new software solution to be used during coronary interventions
- Scientific TitleEvaluation of workflow improvements of new software solution to be used during coronary interventions
- ACRONYM
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedCoronary artery disease
- 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-jun-2016
- Target number of participants90
- InterventionsThe 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.
- Primary outcomeQualitative feedback of the use of the study device in order to establish an optimized workflow and usability.
- Secondary outcomeImage data, adverse events, adverse device effects and device deficiencies that could have led to a serious adverse event.
- TimepointsThe total duration of the study is expected to take approximately 9 months.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Roland Bullens
- CONTACT for SCIENTIFIC QUERIES Roland Bullens
- Sponsor/Initiator Philips Medical Systems Nederland B.V.
- Funding
(Source(s) of Monetary or Material Support)
Philips Medical Systems Nederland B.V.
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD25-jun-2015 - 23-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl