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:
EG000
Title:
DCB Subjects
Description:
The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
Basic Catheter Specifications
* Guidewire: 0.035"
* Balloon Length: 40/80/120 mm
* Sheath Compatibility: greater than or equal to 6 French
* Balloon Diameter: 4/5/6 mm
* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Deaths Number Affected:
34
Deaths Number At Risk:
None
Serious Number Affected:
177
Serious Number At Risk:
200
Other Number Affected:
192
Other Number At Risk:
200
Study:
NCT03421561
Results Section:
NCT03421561
Adverse Events Module:
NCT03421561