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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City (Other)

Overall Status

Unknown status

CT.gov ID

NCT04177615

Collaborator

(none)

109

Enrollment

Arms

13.4

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Basilar Artery Occlusion	Procedure: Thromboectomy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 19, 2019

Anticipated Primary Completion Date :

Nov 19, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thromboectomy and rTPA use thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour	Procedure: Thromboectomy Thromboectomy in Basilar Artery Occlusion patients
No Intervention: rTPA( recombinant tissue plasminogen activator ) use rtpa for patient with basilar artery occlusion stroke in 24 hour

Arm

Intervention/Treatment

Experimental: Thromboectomy and rTPA

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

Procedure: Thromboectomy

Thromboectomy in Basilar Artery Occlusion patients

No Intervention: rTPA( recombinant tissue plasminogen activator )

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

Outcome Measures

Primary Outcome Measures

NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission [24 hours from admission]
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
Survival rate in patients with Basilar Artery Occlusion Stroke [3 months from admission]
Survival rate in patients with Basilar Artery Occlusion Stroke

Secondary Outcome Measures

mRS in patients with Basilar Artery Occlusion Stroke [3 months from admission]
mRS in patients with Basilar Artery Occlusion Stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

Study Chair: TUAN D Tran, MD, UMP university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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 City

ClinicalTrials.gov Identifier:

NCT04177615

Other Study ID Numbers:

yds2019

First Posted:

Nov 26, 2019

Last Update Posted:

Nov 26, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by 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 City

Ischemic stroke

Basilar Artery Occlusion

Additional relevant MeSH terms:

Stroke

Arterial Occlusive Diseases

Study Results

No Results Posted as of Nov 26, 2019