Intracranial Arterial Stenosis in Young Patients | NCT05844176

Studies
Intracranial Arterial Stenosis in Young Patients

NCT05844176

Sponsor

Capital Medical University

Status

Recruiting

Last Update Posted

Apr 24, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Intracranial Arterial Stenosis

Interventions

Routine clinical treatment

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2030Estimated

First Submitted Date

Apr 25, 2023

First Submission Date that Met QC Criteria

Apr 25, 2023

First Posted Date

May 6, 2023Actual

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

Apr 21, 2025

Last Update Posted Date

Apr 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptomatic intracranial arterial stenosis			Other: Routine clinical treatment
Asymptomatic intracranial arterial stenosis			Other: Routine clinical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine clinical treatment	Other	Routine clinical treatment is based on the latest international and local guidelines	Asymptomatic intracranial arterial stenosis Symptomatic intracranial arterial stenosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ischemic stroke in territory of qualifying artery		1 year

Secondary Outcomes

Measure	Description	Time Frame
Ischemic stroke in other territory		1 year
Any stroke		1 year
Death

Other Outcomes

Measure	Description	Time Frame
Ischemic stroke in the territory of qualifying artery		3 year
Ischemic stroke in other territory		3 year
Any stroke

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age < 45 years.
stenosis of a major intracranial artery.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Patients with intracranial arterial stenosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xunming Ji, MD	Contact	010-83199439		jixm@ccmu.edu.cn
Chuanjie Wu, MD	Contact	010-83199439		wuchuanjie@xwhosp.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suzhou Municipal Hoapital	Recruiting	Suzhou	Anhui		China