NCT03153865

Brief Summary

This is a prospective, multicenter, observational study, aiming at comparing the Safety and effectiveness among the different surgical treatment of unruptured intracranial aneurysms in China, so as to improve the diagnosis and treatment of unruptured 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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration 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

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

May 11, 2017

Last Update Submit

May 12, 2017

Conditions

Unruptured Cerebral AneurysmTreatment Strategy

Outcome Measures

Primary Outcomes (1)

  • mortality and disability

    the rate of death and disable

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • recurrence rate

    1 month, 6 months and 1 year after surgery;

  • progression of disease

    1 month, 6 months and 1 year after conservative treatment；

Other Outcomes (1)

  • the level of psychological states changes

    1 month, 6 months and 1 year after been aware of the disease

Eligibility Criteria

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

patients diagnosed with unruptured intracranial saccular aneurysm at all age.

You may qualify if:

  • patients diagnosed with unruptured intracranial saccular aneurysm on CTA, MRA or DSA.
  • patients willing to participate in this clinical trial and attach to regular follow up.

You may not qualify if:

  • intracranial aneurysm correlating to AVM.
  • intracranial non-saccular aneurysm.
  • the rupture or unrpture of the aneurysm confirmed on CTA、MRA or DSA.
  • patients unwilling to participate in this clinical trial and attach to regular follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

  • Qinghai Huang, MD

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yang, MD

CONTACT

+86 1592119631215921196312@163.com

Hongjian Zhang, MD

CONTACT

+86 13961616656chzhanghj2012@me.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

June 2, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 15, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)