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 @ 11:51 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
NCT ID:
NCT03421561
Group ID:
EG001
Title:
PTA Subjects
Description:
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Basic Catheter Specifications
* Guidewire: 0.035"
* Balloon Length: 40/80/120 mm
* Sheath Compatibility: greater to or equal to 6 French
* Balloon Diameter: 4/5/6 mm
* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Deaths Number Affected:
19
Deaths Number At Risk:
None
Serious Number Affected:
85
Serious Number At Risk:
100
Other Number Affected:
95
Other Number At Risk:
100
Study:
NCT03421561
Results Section:
NCT03421561
Adverse Events Module:
NCT03421561