The Coexistence of Atherosclerotic Intracranial Arterial... | NCT02795078

Status Module

Record Verification Date

Nov 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

Oct 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Jun 5, 2016

First Submission Date that Met QC Criteria

Jun 8, 2016

First Posted Date

Jun 9, 2016Estimated

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

Nov 3, 2017

Last Update Posted Date

Nov 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

liuxingju, Ministry of Science and Technology of the People´s Republic of China, Ministry of Science and Technology of the People´s Republic of ChinaSponsor-Investigator

Lead Sponsor

liuxingjuOTHER_GOV

Collaborators

Name	Class
National Clinical Research Center for Neurological Diseases	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial stenosis.

Detailed Description

Based on prospective data of patients with symptomatic or asymptomatic ICA stenosis admitted to Beijing Tiantan Hospital between Jan 2015 and July 2016, all patients underwent brain CTA / MRA/DSA. Investigators determined the number of the patients with intracranial aneurysms, calculated overall prevalence of the coexistence of atherosclerotic ICA stenosis with aneurysms and analyzed the clinical features.

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

700Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conservative treatment	Drug
Aneurysms clipping	Procedure
Interventional embolization forAneurysms	Procedure
stenting for stenosis	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
new stroke events during perioperative period		perioperative period

Secondary Outcomes

Measure	Description	Time Frame
stroke events during follow up		6 months after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSA identified the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms
Stenosis caused by atherosclerosis

Exclusion Criteria:

patients do not agree
Stenosis caused by no atherosclerosis disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patient who had the coexistence of intracranial Arterial Stenosis With Intracranial Aneurysms were included in this study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
liu xingju, MD	Contact	8615011476305		liuxingju006@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital Capital Medical University	Recruiting	Beijing	Beijing Municipality	0086	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37139814	Derived	Yin Z, Zhang Q, Zhao Y, Lu J, Ge P, Xie H, Wu D, Yu S, Kang S, Zhang Q, Zhang Y, Zhang D, Zhao J, Liu X. Prevalence and Procedural Risk of Intracranial Atherosclerotic Stenosis Coexisting With Unruptured Intracranial Aneurysm. Stroke. 2023 Jun;54(6):1484-1493. doi: 10.1161/STROKEAHA.122.041553. Epub 2023 May 4.

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D000072700	Conservative Treatment
D015607	Stents
D003250	Constriction

ID	Term
D013812	Therapeutics
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D008919	Investigative Techniques