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Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital (RARETBAS)

Primary Purpose

Stroke, Acute, Basilar Artery Occlusion

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Thromboectomy

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Ischemic stroke, Basilar Artery Occlusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thromboectomy and rTPA

rTPA( recombinant tissue plasminogen activator )

Arm Description

use thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour

use rtpa for patient with basilar artery occlusion stroke in 24 hour

Outcomes

Primary Outcome Measures

NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission

Survival rate in patients with Basilar Artery Occlusion Stroke

Secondary Outcome Measures

mRS in patients with Basilar Artery Occlusion Stroke

Full Information

NCT ID

NCT04177615

First Posted

November 24, 2019

Last Updated

November 24, 2019

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

1. Study Identification

Unique Protocol Identification Number

NCT04177615

Brief Title

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

Acronym

RARETBAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 19, 2019 (Anticipated)

Primary Completion Date

November 19, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute, Basilar Artery Occlusion

Keywords

Ischemic stroke, Basilar Artery Occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

109 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thromboectomy and rTPA

Arm Type

Experimental

Arm Description

use thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour

Arm Title

rTPA( recombinant tissue plasminogen activator )

Arm Type

No Intervention

Arm Description

use rtpa for patient with basilar artery occlusion stroke in 24 hour

Intervention Type

Procedure

Intervention Name(s)

Thromboectomy

Intervention Description

Thromboectomy in Basilar Artery Occlusion patients

Primary Outcome Measure Information:

Title

NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission

Description

NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission

Time Frame

24 hours from admission

Title

Survival rate in patients with Basilar Artery Occlusion Stroke

Description

Survival rate in patients with Basilar Artery Occlusion Stroke

Time Frame

3 months from admission

Secondary Outcome Measure Information:

Title

mRS in patients with Basilar Artery Occlusion Stroke

Description

mRS in patients with Basilar Artery Occlusion Stroke

Time Frame

3 months from admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DUNG U Tran Nguyen

Phone

0902610832

uyendungtrannguyen@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

THANG H Nguyen, MD, PhD

Phone

033962478

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

TUAN D Tran, MD

Organizational Affiliation

UMP university

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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