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Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 143 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description revised
    • Collaborators: details revised at 1 of 4 entries
  2. Eligibility criteria shortened, about 2 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain. This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS \<7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.
Trial Details
NCT Number NCT07672795
Lead Sponsor The First Affiliated Hospital of University of Science and Technology of China
Collaborators: Dalian Municipal Central Hospital, Linyi People's Hospital, Fujian Zhangzhou hospital, Shanghai Minhang District Central Hospital
Conditions
(from sponsor)		 Acute Ischemic Stroke, Basilar Artery Occlusion, Large Ischemic Core
Related terms Ischemic Stroke
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov