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Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial: study protocol.

Arturo Renú1,2, Patricia de la Riva3, Raquel Delgado-Mederos4

  • 1Comprehensive Stroke Center, Hospital Clinic de Barcelona, Barcelona, Barcelona, Spain.

Stroke and Vascular Neurology
|December 3, 2025
PubMed
Summary

Rescue intra-arterial thrombolysis after mechanical thrombectomy may improve outcomes for large vessel occlusion stroke patients. The CHOICE 2 trial investigates if alteplase infusion post-thrombectomy enhances functional recovery.

Keywords:
Clinical TrialIschemic StrokePerfusion ImagingRandomized Controlled TrialThrombolytic Therapy

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Area of Science:

  • Neurology
  • Interventional Neuroradiology
  • Clinical Trials

Background:

  • Mechanical thrombectomy (MT) is a standard treatment for large vessel occlusion (LVO) stroke.
  • The role of rescue intra-arterial thrombolysis following successful MT requires further validation in randomized trials.
  • Optimizing reperfusion strategies is crucial for improving clinical outcomes in acute ischemic stroke.

Purpose of the Study:

  • To confirm if adjunctive intra-arterial alteplase administered after successful MT improves clinical outcomes in LVO stroke patients.
  • The Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial aims to provide definitive evidence on this therapeutic strategy.

Main Methods:

  • A multicenter, randomized, open-label, phase III trial with blinded endpoint assessment.
  • 440 adult patients with symptomatic LVO undergoing successful or complete reperfusion via MT will be enrolled.
  • Patients will be randomized 1:1 to receive intra-arterial thrombolysis (alteplase infusion) or standard care.

Main Results:

  • The primary outcome is the proportion of patients achieving excellent functional outcome (modified Rankin Scale score of 0-1) at 90 days.
  • Secondary outcomes include assessment of hypoperfusion, infarct expansion, functional independence (Barthel Index), quality of life, mortality, and symptomatic intracerebral hemorrhage.

Conclusions:

  • This trial is designed to provide robust evidence on the efficacy of rescue intra-arterial thrombolysis in LVO stroke patients.
  • Findings will determine if adjunctive alteplase improves functional outcomes and safety profiles after successful mechanical thrombectomy.