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

March 4, 2024 updated by: King's College Hospital NHS Trust
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients Treated with pipeline embolization devices during 2021 and 2022

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Done at 30 days post procedural
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
Done at 30 days post procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Done at >30days up to 1 year post procedural
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
Done at >30days up to 1 year post procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 317314

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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