New Therapeutic System of Unruptured Intracranial Aneurys... | NCT03153865

Studies
New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population

NCT03153865

Sponsor

Changhai Hospital

Status

Unknown status

Last Update Posted

May 15, 2017Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Unruptured Cerebral Aneurysm
Treatment Strategy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2017Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

May 11, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2017

Last Update Posted Date

May 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality and disability	the rate of death and disable	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
recurrence rate		1 month, 6 months and 1 year after surgery;
progression of disease	enlarge or ruptured of the aneurysm	1 month, 6 months and 1 year after conservative treatment；

Other Outcomes

Measure	Description	Time Frame
the level of psychological states changes	The Sheet for Affective Disorders was used to record the level of psychological states changes in every participant when they were aware of the disease.	1 month, 6 months and 1 year after been aware of the disease

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients diagnosed with unruptured intracranial saccular aneurysm at all age.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pengfei Yang, MD	Contact	+86 15921196312		15921196312@163.com
Hongjian Zhang, MD	Contact	+86 13961616656		chzhanghj2012@me.com

Overall Officials

Name	Affiliation	Role
Qinghai Huang, MD	Changhai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhai Hospital	Recruiting	Shanghai	Shanghai Municipality	200433	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided