Outcome study of the Pipeline Vantage Embolization Device (second version) in unruptured (and ruptured) aneurysms (PEDVU(R) study).
Thomas C Booth, Ahmed Bassiouny, Jeremy Lynch...
https://pubmed.ncbi.nlm.nih.gov/38071557Actively Recruiting
All Genders
ID07175519
Safety and Efficacy of Aneurysms Treated With Endovascular Devices
Led by King's College London · Updated on 2025-09-16
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of recent endovascular devices used to treat brain aneurysms. This observational study focuses on patients with brain aneurysms, stroke, or intracranial hemorrhages who undergo endovascular treatment. The goal is to understand factors that predict if an aneurysm might recur after treatment. The treatments studied involve endovascular procedures using catheters with devices such as coils, stents, flow diverters, and intrasaccular devices to manage aneurysms. These treatments are evaluated as part of routine care without altering standard practices. Participants undergo evaluations shortly after the procedure (around 30 days) and continue to be monitored long-term for up to five years. Researchers collect data on aneurysm recurrence and other outcomes during this time, using clinical information and imaging from standard follow-ups. No additional interventions beyond usual care are required.
CONDITIONS
Brief Title
Safety and Efficacy of Aneurysms Treated With Endovascular Devices
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- All patients undergoing endovascular aneurysm treatment.
You will not qualify if you...
- Patients undergoing endovascular treatment for conditions other than aneurysm, such as stroke or arteriovenous malformations.
- Insufficient background data available to determine aneurysm size and device used.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants receive endovascular treatment of aneurysms using devices such as coils, stents, flow diverters, or intrasaccular devices.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 5 years
Participants are monitored to evaluate aneurysm recurrence and device efficacy over time.
Short-term visit at 30 days post-procedure and multiple long-term visits up to 5 years
Trial Site Locations
Total: 1 location
1
Kings College Hospital, London
London, United Kingdom
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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