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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05626504
Acronym
PEDVU
Enrollment
50
Registered
2022-11-23
Start date
2022-10-27
Completion date
2025-03-31
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Aneurysm, Intracranial Hemorrhages, Stroke

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

Interventions

DEVICEPipeline Embolization Device with Vantage Technology

Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.

Sponsors

King's College Hospital NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate 30-day morbidity ratesDone at 30 days post proceduralWe will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure
Evaluate 30-day mortality ratesDone at 30 days post proceduralWe will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure

Secondary

MeasureTime frameDescription
Evaluate 1-year morbidity ratesDone at >30days up to 1 year post proceduralWe will evaluate long term clinical outcome in the form of morbidity rates \>30days up to 1 year after the procedure
Evaluate 1-year mortality ratesDone at >30days up to 1 year post proceduralWe will evaluate long term clinical outcome in the form of mortality rates \>30days up to 1 year after the procedure

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026