The Chemical Optimization of Cerebral Embolectomy trial: Study protocol

Area of Science:

• Neurology
• Interventional Neurology
• Stroke Medicine

Background:

• Large vessel occlusion stroke requires effective reperfusion strategies.
• Mechanical thrombectomy is a primary treatment, but suboptimal reperfusion occurs.
• The role of rescue intraarterial thrombolysis in this setting remains unquantified by randomized trials.

Purpose of the Study:

• To determine if rescue intraarterial thrombolysis improves reperfusion compared to placebo.
• To assess effectiveness in patients with large vessel occlusion stroke and suboptimal reperfusion post-thrombectomy.

Main Methods:

• A multicenter, randomized, placebo-controlled, double-blind, phase 2b trial.
• 200 patients with large vessel occlusion stroke and modified treatment in cerebral ischemia (mTICI) score ≤2b post-thrombectomy were enrolled.
• Intervention involved a 20-30 minute intraarterial infusion of recombinant tissue plasminogen activator or placebo.

Main Results:

• The primary outcome is the proportion of patients with improved mTICI score 10 minutes post-treatment.
• Secondary outcomes include modified Rankin Scale shifts, infarct expansion, and infarction volume.
• Safety outcomes include mortality and symptomatic intracerebral hemorrhage.

Conclusions:

• The study will provide crucial evidence on the efficacy of rescue intraarterial thrombolysis.
• Findings will inform treatment decisions for large vessel occlusion stroke patients with incomplete reperfusion after mechanical thrombectomy.