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Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

NCT05631847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2025-11-25

No results posted yet for this study

Summary

Currently, both intravenous thrombolysis (IVT) followed by endovascular treatment (EVT) and EVT alone are widely used for the treatment of acute ischemic stroke (AIS) caused by basilar artery occlusion (BAO) (AIS-BAO), but no direct comparison of their efficacy and safety was reported. Only a limited number of cohort and registry studies have preliminarily compared the two strategies in the treatment of AIS-BAO, with results generally indicating that IVT followed by EVT was slightly superior to EVT alone. However, these findings are generally limited by small sample sizes, heterogeneous inclusion and exclusion criteria, different endpoint definitions, and distinct study designs, leading to inconsistent conclusions. Therefore, this study plans to conduct a multicentre, prospective, open-label, blinded endpoint evaluation, randomized controlled trial comparing the efficacy and safety of IVT followed by EVT and EVT alone in the treatment of patients with AIS-BAO who are eligible for both treatment strategies within 4.5 hours of symptom onset. This study intends to include patients with AIS due to BAO fulfilling the following inclusion criteria: patients with AIS caused by BAO confirmed by CTA/MRA/DSA; IVT can be started within 4.5 hours after symptoms onset; Age ≥ 18 years old; NIHSS score ≥ 6.

The primary endpoint of the study is the proportion of patients achieving mRS ≤ 2 at 90±14 days after stroke onset.

Conditions

  • Acute Ischemic Stroke
  • Basilar Artery Occlusion
  • Thrombosis
  • Alteplase
  • Endovascular Treatment

Interventions

PROCEDURE

Endovascular treatment

It is the emergency surgical removal of emboli which are blocking blood circulation. The strategies that were used for endovascular treatment included stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intraarterial thrombolysis (with alteplase), or combinations of these approaches that were left to the discretion of the treating team.

DRUG

Intravenous thrombolysis (Alteplase)

Alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.

Sponsors & Collaborators

  • Sichuan Provincial People's Hospital

    collaborator OTHER

  • Sichuan Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Fu-Qiang Guo, M.D. · Sichuan Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2025-08-28
Completion
2025-08-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631847 on ClinicalTrials.gov