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NCT05626504 Clinical Trial

Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms

Stroke Clinical Trial

— PEDVU  

Official title:
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05626504
Other study ID # 317314
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 27, 2022
Est. completion date March 31, 2025

Study information
Verified date March 2024
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date March 31, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Pipeline Embolization Device with Vantage Technology
Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.

Locations
Country Name City State
United Kingdom Kings College Hospital London

Sponsors (1)
Lead Sponsor Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Evaluate 1-year morbidity rates 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
Secondary Evaluate 1-year mortality rates 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
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