NCT05646108

Brief Summary

The scope of this trial is the collection and analysis of the important safety outcomes in the real world, related to the use of the Tubridge flow diverter in the treatment of intracranial aneurysms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

April 18, 2018

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

5.1 years

First QC Date

May 29, 2022

Last Update Submit

December 2, 2022

Conditions

Intracranial Aneurysm

Keywords

flow diverterIntracranial aneurysmcerebral aneurysm

Outcome Measures

Primary Outcomes (1)

  • The primary end point was the event-free survival rate at 12 months(Plus 0.5 month).

    defined as the occurrence of morbidity (ispontaneous rupture of the target aneurysm causing subarachnoid hemorrhage or cavernous carotid fistula, intraparenchymal hemorrhage (IPH)(both ipsilateral and contralateral), ischemic stroke, and permanent cranial neuropathy,or death within 12 months(Plus 0.5 month) post-treatment.For the Tubridge flow diverter, this endpoint will be based upon the evaluation of clinical event committee, identification of patients with neurologic clinical events after Tubridge flow diverter treatment, including but not limited: Spontaneous rupture of the target aneurysm, Intraparenchymal hemorrhage, Ischemic stroke, cranial neuropathy.Transient ischemic stroke without clinical adverse events was not included.

    12 months (Plus 0.5 month)

Secondary Outcomes (6)

  • The clinical outcome defined by the mRS at 12 months (Plus 0.5 month) after aneurysm treatment.

    12 months (Plus 0.5 month)

  • Occurrence of ipsilateral major stroke or neurovascular death in 1 months (Plus 7 days), including but not limited: Spontaneous rupture of the target aneurysm, ipsilateral intraparenchymal hemorrhage, ipsilateral ischemic stroke, cranial neuropathy.

    1 months (Plus 7 days)

  • The event-free survival rate at 24 months(Plus 0.5 month);

    24 months(Plus 0.5 month)

  • The event-free survival rate at 36 months(Plus 0.5 month);

    36 months(Plus 0.5 month)

  • The event-free survival rate at 48 months(Plus 0.5 month);

    48 months(Plus 0.5 month)

  • +1 more secondary outcomes

Interventions

Endovascular treatmentDEVICE

Endovascular treatment

Eligibility Criteria

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

Child, Adult, Older Adult

You may qualify if:

  • \. received Tubridge flow diverter treatment for intracranial aneurysm after the date of regulatory approval in China

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Jianmin Liu, Ph.D

    Changhai Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2022

First Posted

December 12, 2022

Study Start

April 18, 2018

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 12, 2022

Record last verified: 2022-12

Locations

CN(1)