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SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO

Study acronym: SUPERSTAR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital to Shanghai Jiao Tong University Affiliated Sixth People's Hospital
    • Start date changed from estimate of Sep 15, 2026 to Sep 17, 2026
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Notable Start date: Jul 15, 2026 to Sep 15, 2026v5
  3. Minor Primary completion moved earlier from Apr 30, 2028 to Dec 30, 2027
    • Study completion moved earlier from Aug 30, 2028 to Mar 30, 2028
    • Start date: Jul 1, 2026 to Jul 15, 2026
    v4
  4. Notable Start date: May 1, 2026 to Jul 1, 2026v3
  5. Minor Secondary endpoints: details revised at 3 of 4 entriesv2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Eligible patients with acute ischemic stroke due to internal carotid artery intracranial segment and/or middle cerebral artery M1 occlusion will be randomized 1:1 to receive either aspiration using a super large bore catheter (inner diameter ≥0.080 inch) or stent retriever thrombectomy (allowing balloon guiding catheters or intermediate catheters with inner diameter \<0.080 inch). The primary outcome is the ordinal modified Rankin Scale score at 90 days post-procedure. Key secondary outcomes include the proportion of patients with mRS 0-2 at 90 days, change in NIHSS at 24 hours and 7 days, and various angiographic and safety endpoints. The trial plans to enroll 708 patients across approximately 30 centers in China. The total study duration is 24-36 months, with each patient participating for 3 months.
Trial Details
NCT Number NCT07555977
Lead Sponsor Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions
(from sponsor)
Acute Ischemic Stroke
Related terms Ischemic Stroke
Enrollment 708 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov