A Cohort Study on Thrombectomy for Stroke | NCT04637074

Studies
A Cohort Study on Thrombectomy for Stroke

NCT04637074

Sponsor

Ning Wang, MD., PhD.

Status

Unknown status

Last Update Posted

Dec 29, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Ischemic Stroke

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

Nov 2021

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

Nov 15, 2020Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Nov 15, 2020

First Submission Date that Met QC Criteria

Nov 15, 2020

First Posted Date

Nov 19, 2020Actual

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

Dec 27, 2021

Last Update Posted Date

Dec 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ning Wang, MD., PhD., Director of Neurology department, First Affiliated Hospital of Fujian Medical UniversitySponsor-Investigator

Lead Sponsor

Ning Wang, MD., PhD.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The cerebral collateral circulation refers to the subsidiary network of vascular channels that stabilize cerebral blood flow when principal conduits fail. Collateral status differs among patients with acute ischemic stroke. Relatively sparse attention has been devoted to the role of baseline collateral circulation in patients with acute ischemic stroke who are candidates for revascularization. This study aim to investigate the correlation between baseline collateral circulation and the likelihood of opening of an arterial occlusion, the extent of reperfusion, tissue injury and clinical impairment.

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

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified Rankin Scale	Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years.
Mechanical thrombectomy initiated within 24 hours after onset
CT perfusion can be performed before the initiation of thrombectomy and 24h after thrombectomy

Exclusion Criteria:

Contraindication to imaging with contrast agents
Delay between imaging and beginning of thrombectomy > 90 minutes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients experiencing brain infarction complicating the large-vessel occlusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying M Fu, MD	Contact	+8613920263688		fuying@fjmu.eu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, First Affiliated Hospital of Fujian Medical University	Recruiting	Fuzhou		350000	China

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided