Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
NCT ID:
NCT03663257
Group ID:
EG000
Title:
AneurysmFlow Observational Cohort
Description:
Subjects with unruptured, \>5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent enrolled at the centers participating in this CARO study.
AneurysmFlow: AneurysmFlow R1.0 is an approved (CE labeled, cleared in US, Canada and Argentina), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It provides color coded and vector field representation of a digital subtraction angiography (DSA). It can quantify blood flow rates in the artery based on DSA and 3-D Rotational Angiogram (3DRA) data. It can visualize blood flow patterns in an aneurysm based on DSA data. Specifically, it calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric flow rate quotient before and after Flow Diverter Stent (FDS) implantation in the region of interest. It is manufactured by Philips Medical Systems B.V., a Philips Healthcare company.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
132
Other Number Affected:
4
Other Number At Risk:
132
Study:
NCT03663257
Results Section:
NCT03663257
Adverse Events Module:
NCT03663257