Randomized Assessment of Rapid Endovascular Treatment in... | NCT04177615

Studies
Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital

NCT04177615

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Status

Unknown status

Last Update Posted

Nov 26, 2019Actual

Enrollment

109Estimated

Phase

Not Applicable

Conditions

Stroke, Acute
Basilar Artery Occlusion

Interventions

Thromboectomy

Countries

Not provided

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2019Estimated

Primary Completion Date

Nov 19, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Nov 24, 2019

First Submission Date that Met QC Criteria

Nov 24, 2019

First Posted Date

Nov 26, 2019Actual

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 24, 2019

Last Update Posted Date

Nov 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tran Nguyen Uyen Dung, Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery occlusion stroke in 115 hospital, University of Medicine and Pharmacy at Ho Chi Minh CityPrincipal Investigator

Lead Sponsor

University of Medicine and Pharmacy at Ho Chi Minh CityOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

This is a prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Detailed Description

Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known. Although basilar artery occlusion has been reported in 2 per 1000 autopsy cases, basilar artery thrombosis may, in stroke registries, explain as many as 27% of ischemic strokes occurring in the posterior circulation.Various treatments were tried in groups of patients with vertebrobasilar territory infarction but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thromboectomy and rTPA	Experimental	use thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour	Procedure: Thromboectomy
rTPA( recombinant tissue plasminogen activator )	No Intervention	use rtpa for patient with basilar artery occlusion stroke in 24 hour

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thromboectomy	Procedure	Thromboectomy in Basilar Artery Occlusion patients	Thromboectomy and rTPA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission	NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission	24 hours from admission
Survival rate in patients with Basilar Artery Occlusion Stroke	Survival rate in patients with Basilar Artery Occlusion Stroke	3 months from admission

Secondary Outcomes

Measure	Description	Time Frame
mRS in patients with Basilar Artery Occlusion Stroke	mRS in patients with Basilar Artery Occlusion Stroke	3 months from admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admit to 115 hospital in 24h of Basilar Artery Occlusion Stroke
NIHSS > 4 points

Exclusion Criteria:

Patients refuse to participate in studies
Patients with contraindication of either rTPA or thromboectomy

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DUNG U Tran Nguyen	Contact	0902610832		uyendungtrannguyen@gmail.com
THANG H Nguyen, MD, PhD	Contact	033962478

Overall Officials

Name	Affiliation	Role
TUAN D Tran, MD	UMP university	Study Chair

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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