History of Changes for Study: NCT05626504

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			November 22, 2022	None (earliest Version on record)
2			March 4, 2024	Recruitment Status, Study Status and Contacts/Locations

Comparison Format:

Study NCT05626504
Submitted Date: November 22, 2022 (v1)

Study Identification


Unique Protocol ID:	317314
Brief Title:	Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms (PEDVU)
Official Title:	Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Secondary IDs:

Study Status


Record Verification:	November 2022
Overall Status:	Recruiting
Study Start:	October 27, 2022
Primary Completion:	March 1, 2025 [Anticipated]
Study Completion:	March 31, 2025 [Anticipated]

First Submitted:	November 1, 2022
First Submitted that Met QC Criteria:	November 22, 2022
First Posted:	November 23, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	November 22, 2022
Last Update Posted:	November 23, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	King's College Hospital NHS Trust
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring:

Study Description


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
Detailed Description:

Study Design

Groups and Interventions


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

Outcome Measures


Primary Outcome Measures:
1.	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
2.	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
Secondary Outcome Measures:
1.	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
2.	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

Eligibility


Study Population:	Patients Treated with pipeline embolization devices during 2021 and 2022
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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.

Contacts/Locations


Locations:	United Kingdom
	Kings College Hospital [Recruiting] London, United Kingdom Contact:Contact: Thomas Booth 02032994828 thomasbooth@nhs.net

References


Citations:	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. PubMed 31727754
Links:
Available IPD/Information: