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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: March 1, 2025

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • King’s College Hospital NHS Trust
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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