Brain AneurysmPEDVUNCT05626504
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
An observational study of Brain Aneurysm and Intracranial Hemorrhages, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Aneurysm, Intracranial Hemorrhages, Stroke
- What is being tested?
- Pipeline Embolization Device with Vantage Technology
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Treated with pipeline embolization devices during 2021 and 2022
Who may be able to join
- All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
- MRA and/or DSA (or tomographic angiography) available for follow up
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms
- Conditions
- Brain Aneurysm, Intracranial Hemorrhages, Stroke
- Being tested
- Pipeline Embolization Device with Vantage Technology
- Medical subject headings
- Intracranial Aneurysm, Intracranial Hemorrhages, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipeline Embolization Device with Vantage TechnologyDevice
Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate 30-day morbidity rates
We will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure
Measured: Done at 30 days post procedural
Evaluate 30-day mortality rates
We will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure
Measured: Done at 30 days post procedural
Secondary outcomes (2)
Evaluate 1-year morbidity rates
We will evaluate long term clinical outcome in the form of morbidity rates >30days up to 1 year after the procedure
Measured: Done at >30days up to 1 year post procedural
Evaluate 1-year mortality rates
We will evaluate long term clinical outcome in the form of mortality rates >30days up to 1 year after the procedure
Measured: Done at >30days up to 1 year post procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start27 Oct 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626504
- Sponsor's protocol ID
- 317314
- Acronym
- PEDVU
- Status last verified
- Mar 2024
- First submitted
- 1 Nov 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
- ClinicalTrials.gov ID
- NCT05626504
- Acronym / sponsor ID
- PEDVU / 317314
- Conditions
- Brain Aneurysm, Intracranial Hemorrhages, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Treated with pipeline embolization devices during 2021 and 2022
Key inclusion criteria (2 listed)
- All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
- MRA and/or DSA (or tomographic angiography) available for follow up
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pipeline Embolization Device with Vantage TechnologyFlow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery. | Device | – |
Primary outcome
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
2 secondary outcomes
Evaluate 1-year morbidity rates
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 31727754Atasoy 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aneurysm and Intracranial Hemorrhages, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate 30-day morbidity rates (time frame: Done at 30 days post procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.