NCT04177615

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 24, 2019

Last Update Submit

November 24, 2019

Conditions

Stroke, AcuteBasilar Artery Occlusion

Keywords

Ischemic strokeBasilar Artery Occlusion

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • mRS in patients with Basilar Artery Occlusion Stroke

    3 months from admission

Study Arms (2)

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

ThromboectomyPROCEDURE

Thromboectomy in Basilar Artery Occlusion patients

Thromboectomy and rTPA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • TUAN D Tran, MD

    UMP university

    STUDY CHAIR

Central Study Contacts

DUNG U Tran Nguyen

CONTACT

0902610832uyendungtrannguyen@gmail.com

THANG H Nguyen, MD, PhD

CONTACT

033962478

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery occlusion stroke in 115 hospital

Study Record Dates

First Submitted

November 24, 2019

First Posted

November 26, 2019

Study Start

November 19, 2019

Primary Completion

November 19, 2020

Study Completion

December 30, 2020

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share