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Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke

Study acronym: ANGEL-ICAS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Enrollment reopenedv3 Show 5 more changesShow less
    • Enrollment increased: 322 → 486 participants
    • Study completion pushed from Jun 1, 2027 to Jul 1, 2027
    • Eligibility criteria expanded, about 215 words
    • Secondary endpoints: 12 to 13
    • Study site revised
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Jul 1, 2025 to Jul 3, 2025
    • Site contact updated
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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The ANGEL-ICAS trial is a multicenter, prospective, randomized, open-label, blinded-endpoint study designed to determine whether rescue balloon angioplasty is noninferior to rescue stenting in patients with intracranial atherosclerosis-related acute ischemic stroke who have residual intracranial arterial stenosis of at least 50% after endovascular treatment and require additional rescue therapy. A total of 486 eligible participants will be randomly assigned in a 1:1 ratio to the balloon angioplasty group or the stenting group. In the balloon angioplasty group, rescue stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate. In the stenting group, balloon angioplasty may be performed in conjunction with stent implantation when clinically indicated. Both groups will receive standard medical management according to the study protocol. The primary outcome is the proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0-2, at 90 days after randomization. Key safety outcomes include symptomatic intracranial hemorrhage within 48 hours, any intracranial hemorrhage within 48 hours, and all-cause mortality at 90 days
Trial Details
NCT Number NCT07026331
Lead Sponsor Beijing Anzhen Hospital
Conditions
(from sponsor)
Acute Ischemic Stroke, Intracranial Atherosclerosis ICAS
Related terms Ischemic Stroke
Enrollment 486 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov