Related Experiment Video
Updated: Jan 27, 2026
Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
The randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute
Kentaro Suzuki1, Kazumi Kimura1, Masataka Takeuchi2
1Department of Neurology, Nippon Medical School, Tokyo, Japan.
Insights
Direct endovascular therapy (EVT) without intravenous thrombolysis (IVT) may be a safe and effective alternative for acute stroke patients with large-vessel occlusion. This clinical trial compares direct EVT to bridging therapy to determine optimal treatment strategies.
Area of Science:
- Neurology
- Interventional Cardiology
- Emergency Medicine
Background:
- Bridging therapy combining endovascular therapy (EVT) and intravenous thrombolysis (IVT) improves outcomes in acute stroke with large-vessel occlusion.
- However, IVT increases the risk of hemorrhagic complications, prompting investigation into alternatives.
Purpose of the Study:
- To clarify the efficacy and safety of direct EVT compared to bridging therapy in acute stroke patients.
- To determine if direct EVT is a viable alternative to bridging therapy for anterior circulation large-vessel occlusions.
Main Methods:
- A multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial.
- 200 patients with internal carotid artery and M1 occlusion stroke were randomized to receive either direct EVT or bridging therapy.
- Primary efficacy endpoint: modified Rankin Scale score of 0-2 at 90 days; safety endpoint: intracranial hemorrhage at 24 hours.
Main Results:
- This section is not yet available as the study is ongoing.
- The study aims to enroll 100 patients in each arm.
- Data on primary efficacy and safety outcomes will be analyzed upon study completion.
Conclusions:
- This trial will provide crucial evidence on the optimal treatment strategy for acute ischemic stroke.
- Findings may support the recommendation of direct EVT as a routine clinical strategy, particularly in stroke centers with endovascular capabilities.
Rationale:
Bridging therapy with endovascular therapy (EVT) and intravenous thrombolysis (IVT) has been reported to improve outcomes for acute stroke patients with large-vessel occlusion in the anterior circulation. While the IVT may increase the reperfusion rate, the risk of hemorrhagic complications increases. Whether EVT without IVT (direct EVT) is equally effective as bridging therapy in acute stroke remains unclear.
Aim:
This randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator for acute stroke with ICA and M1 occlusion aims to clarify the efficacy and safety of direct EVT compared with bridging therapy.
Methods And Design:
This is an investigator-initiated, multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial. The target patient number is 200, comprising 100 patients receiving direct EVT and 100 receiving bridging therapy.
Study Outcome:
The primary efficacy endpoint is a modified Rankin Scale score of 0-2 at 90 days. Safety outcome measures are any intracranial hemorrhage at 24 h.
Discussion:
This trial may help determine whether direct EVT should be recommended as a routine clinical strategy for ischemic stroke patients within 4.5 h from onset. Direct EVT would then become the choice of therapy in stroke centers with endovascular facilities.
Trial Registration:
UMIN000021488.
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