- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05626504
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms (PEDVU)
March 4, 2024 updated by: King's College Hospital NHS Trust
In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- Kings College Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients Treated with pipeline embolization devices during 2021 and 2022
Description
Inclusion Criteria:
- All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
- MRA and/or DSA (or tomographic angiography) available for follow up
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate 30-day morbidity rates
Time Frame: Done at 30 days post procedural
|
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
Time Frame: Done at 30 days post procedural
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate 1-year morbidity rates
Time Frame: Done at >30days up to 1 year post procedural
|
We will evaluate long term clinical outcome in the form of morbidity rates >30days up to 1 year after the procedure
|
Done at >30days up to 1 year post procedural
|
Evaluate 1-year mortality rates
Time Frame: Done at >30days up to 1 year post procedural
|
We will evaluate long term clinical outcome in the form of mortality rates >30days up to 1 year after the procedure
|
Done at >30days up to 1 year post procedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2022
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
November 1, 2022
First Submitted That Met QC Criteria
November 22, 2022
First Posted (Actual)
November 23, 2022
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 317314
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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