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

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ClinicalTrials.gov Identifier: NCT05626504
Recruitment Status : Active, not recruiting
First Posted : November 23, 2022
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
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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

Condition or disease Intervention/treatment
Brain Aneurysm Intracranial Hemorrhages Stroke Device: Pipeline Embolization Device with Vantage Technology

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Actual Study Start Date : October 27, 2022
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
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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
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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 Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients Treated with pipeline embolization devices during 2021 and 2022
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 and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05626504


Locations
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United Kingdom
Kings College Hospital
London, United Kingdom
Sponsors and Collaborators
King's College Hospital NHS Trust
More Information
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Publications:

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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT05626504    
Other Study ID Numbers: 317314
First Posted: November 23, 2022    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024

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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
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Intracranial Aneurysm
Aneurysm
Hemorrhage
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases