Brain AneurysmSEATEDNCT07175519
Safety and Efficacy of Aneurysms Treated With Endovascular Devices
An observational study of Brain Aneurysm and Stroke, run by King's College London at 1 site in United Kingdom.
Trial summary
In this project the investigators study the safety and efficacy of the recent endovascular devices used in treatment of brain aneurysms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Aneurysm, Stroke, Intracranial Hemorrhages
- What is being tested?
- Endovascular treatment of aneurysms
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2025to 15 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cerebral aneurysms treated with endovascular devices
Who may be able to join
- All patients undergoing endovascular aneurysm treatment.
Who cannot join
- All endovascular patients NOT undergoing aneurysm treatment e.g. stents used for stroke treatment; devices and materials used for dAVF, AVM treatments.
- Insufficient background data available e.g., to determine size of aneurysm and device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Kings College Hospital, London
London
Thomas Booth, 02032994828, thomasbooth@nhs.net
About this study
In this project the investigators study the safety and efficacy of the recent endovascular devices used in treatment of brain aneurysms.
- Conditions
- Brain Aneurysm, Stroke, Intracranial Hemorrhages
- Being tested
- Endovascular treatment of aneurysms
- Medical subject headings
- Intracranial Aneurysm, Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of aneurysmsDevice
Aneurysm can be treated by endovascular devices using catheters, Treatment modalities can include coils, stents, flow diverters as well as intrasaccular devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate predictive factors of aneurysm recurrence after endovascular device embolization (efficacy).
Change of aneurysm from Raymond Roy (RR) classification I into RR II or RR III and correlating this with factors such as smoking.
Measured: Done at short-term (30 days) post procedural and long term (up to 5 years) post procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2035 (estimated)
- Study completion15 Jan 2035 (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 LondonThe 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175519
- Sponsor's protocol ID
- 287395
- Acronym
- SEATED
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Booth TC, Bassiouny A, Lynch J, Sonwalkar H, Bleakley A, Iqbal A, Minett T, Buwanabala J, Narata AP, Patankar T, Islim FI, Kandasamy N, Balasundaram P, Sciacca S, Siddiqui J, Walsh D, Tolias C, Kailaya-Vasan A, Sultan AA, Abd El-Latif M, Mortimer A, Sastry A. Outcome study of the Pipeline Vantage Embolization Device (second version) in unruptured (and ruptured) aneurysms (PEDVU(R) study). J Neurointerv Surg. 2024 Oct 14;16(11):1136-1144. doi: 10.1136/jnis-2023-020754.
PubMed 38071557
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Aneurysms Treated With Endovascular Devices
- ClinicalTrials.gov ID
- NCT07175519
- Acronym / sponsor ID
- SEATED / 287395
- Conditions
- Brain Aneurysm, Stroke, Intracranial Hemorrhages
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2035 (estimated)
- Study completion
- 15 Jan 2035 (estimated)
- First posted
- 16 Sep 2025 (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 recent endovascular devices used in treatment of brain aneurysms.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cerebral aneurysms treated with endovascular devices
Key inclusion criteria (1 listed)
- All patients undergoing endovascular aneurysm treatment.
Key exclusion criteria (2 listed)
- All endovascular patients NOT undergoing aneurysm treatment e.g. stents used for stroke treatment; devices and materials used for dAVF, AVM treatments.
- Insufficient background data available e.g., to determine size of aneurysm and device.
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 |
|---|---|---|
| Endovascular treatment of aneurysmsAneurysm can be treated by endovascular devices using catheters, Treatment modalities can include coils, stents, flow diverters as well as intrasaccular devices | Device | – |
Primary outcome
Evaluate predictive factors of aneurysm recurrence after endovascular device embolization (efficacy).
Time frame: Done at short-term (30 days) post procedural and long term (up to 5 years) post procedural
Change of aneurysm from Raymond Roy (RR) classification I into RR II or RR III and correlating this with factors such as smoking.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 38071557Booth TC, Bassiouny A, Lynch J, Sonwalkar H, Bleakley A, Iqbal A, Minett T, Buwanabala J, Narata AP, Patankar T, Islim FI, Kandasamy N, Balasundaram P, Sciacca S, Siddiqui J, Walsh D, Tolias C, Kailaya-Vasan A, Sultan AA, Abd El-Latif M, Mortimer A, Sastry A. Outcome study of the Pipeline Vantage Embolization Device (second version) in unruptured (and ruptured) aneurysms (PEDVU(R) study). J Neurointerv Surg. 2024 Oct 14;16(11):1136-1144. doi: 10.1136/jnis-2023-020754.
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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.
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 Stroke, run by King's College London 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 1 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate predictive factors of aneurysm recurrence after endovascular device embolization (efficacy). (time frame: Done at short-term (30 days) post procedural and long term (up to 5 years) post procedural). 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 NCT07175519, 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 16 Sep 2025.