Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
PEDVU
1 other identifier
observational
50
1 country
1
Brief Summary
In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2022
CompletedFirst Submitted
Initial submission to the registry
November 1, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedMarch 5, 2024
March 1, 2024
2.3 years
November 1, 2022
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluate 30-day morbidity rates
We will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure
Done at 30 days post procedural
Evaluate 30-day mortality rates
We will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure
Done at 30 days post procedural
Secondary Outcomes (2)
Evaluate 1-year morbidity rates
Done at >30days up to 1 year post procedural
Evaluate 1-year mortality rates
Done at >30days up to 1 year post procedural
Interventions
Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.
Eligibility Criteria
Patients Treated with pipeline embolization devices during 2021 and 2022
You may qualify if:
- All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
- MRA and/or DSA (or tomographic angiography) available for follow up
You may not qualify if:
- Insufficient background data available e.g., to determine size of aneurysm and pipeline device
- PEDV used for causes other than aneurysms, e.g., fistulas and dissection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kings College Hospital
London, United Kingdom
Related Publications (1)
Atasoy D, Kandasamy N, Hart J, Lynch J, Yang SH, Walsh D, Tolias C, Booth TC. Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU). AJNR Am J Neuroradiol. 2019 Dec;40(12):2094-2101. doi: 10.3174/ajnr.A6314. Epub 2019 Nov 14.
PMID: 31727754BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2022
First Posted
November 23, 2022
Study Start
October 27, 2022
Primary Completion
March 1, 2025
Study Completion
March 31, 2025
Last Updated
March 5, 2024
Record last verified: 2024-03