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 @ 5:14 PM
Ignite Modification Date:
2025-12-25 @ 2:52 PM
NCT ID:
NCT05448950
Group ID:
EG000
Title:
VIG Continued Access
Description:
Patients referred for AVG implant were screened for study eligibility by a member of the research team. If all initial inclusion criteria were met and no exclusion criteria were present, the patient was informed of the study's purpose and invited to participate. Final enrollment eligibility was determined at the time of surgery, after the investigator confirmed the final inclusion criteria were met.
Enrolled subjects were assigned a unique study subject identification number. Written informed consent was obtained from all enrolled patients prior to performing any study procedures.
VIG Continued Access Study: Small skin incisions are made for tunneling the AVG under the skin in a standard manner. The VIG device is provided pre-loaded within a customized catheter-based delivery system for over-the-wire delivery. The VIG is inserted through an introducer sheath placed in the target vein so that the 'vessel end' of the VIG is deployed within the vein, and the 'graft end' extends out of the vein for manual insertion within the AVG. Delivery and deployment are performed under fluoroscopic guidance. The VIG is deployed first, connected to the AVG, then the AVG and VIG are flushed and clamped. The arterial anastomosis is then created using a standard suturing method.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
12
Other Number Affected:
4
Other Number At Risk:
12
Study:
NCT05448950
Results Section:
NCT05448950
Adverse Events Module:
NCT05448950