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Clinical Trial Summary

This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.


Clinical Trial Description

This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old.

In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02441556
Study type Interventional
Source Jinling Hospital, China
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date December 30, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT05827042 - Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion Phase 3
Recruiting NCT05701956 - Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion Phase 3
Completed NCT04751708 - Endovascular Treatment for Acute Basilar Artery Occlusion N/A