NCT07175519

Brief Summary

In this project the investigators study the safety and efficacy of the recent endovascular devices used in treatment of brain aneurysms.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
106mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2025Jan 2035

Study Start

First participant enrolled

January 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2035

Last Updated

September 16, 2025

Status Verified

April 1, 2025

Enrollment Period

10 years

First QC Date

April 15, 2025

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Done at short-term (30 days) post procedural and long term (up to 5 years) post procedural

Interventions

Aneurysm can be treated by endovascular devices using catheters, Treatment modalities can include coils, stents, flow diverters as well as intrasaccular devices

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cerebral aneurysms treated with endovascular devices

You may qualify if:

  • All patients undergoing endovascular aneurysm treatment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings College Hospital, London

London, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38071557BACKGROUND

MeSH Terms

Conditions

Intracranial AneurysmStrokeIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

September 16, 2025

Study Start

January 15, 2025

Primary Completion (Estimated)

January 15, 2035

Study Completion (Estimated)

January 15, 2035

Last Updated

September 16, 2025

Record last verified: 2025-04

Locations