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
Age 18 years or older.
Pre-stroke modified Rankin Scale (mRS) score of 0-1.
Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time.
Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6.
Any intracranial hemorrhage identified on imaging before randomization; or major intracranial hemorrhage, defined as parenchymal hematoma type 1 or type 2, identified on intraprocedural flat-panel CT. Parenchymal hematoma type 1 is defined as blood clots involving less than 30% of the infarcted area, with or without a slight space-occupying effect; parenchymal hematoma type 2 is defined as blood clots involving more than 30% of the infarcted area with a substantial space-occupying effect.
Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset.
Bleeding diathesis, including platelet count below 100 × 10⁹/L, activated partial thromboplastin time greater than 50 seconds, or international normalized ratio greater than 2.0; treatment with a direct oral anticoagulant within the preceding 48 hours; or a history of heparin-induced thrombocytopenia.
Pregnancy or breastfeeding at admission.
Parallel
balloon angioplasty
Procedure/SurgeryBalloon angioplasty treatment followed by standard medical therapy post-procedure.
Stent
Procedure/SurgeryPatients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment.
Proportion of patients with mRS 0-2
Functional independence is defined as a modified Rankin Scale (mRS) score of 0-2. The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Change in NIHSS Score From Baseline to 36 Hours
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating greater neurological impairment. Change will be calculated as the NIHSS score at 36 hours minus the baseline NIHSS score; negative values indicate neurological improvement.
Proportion of Participants With Target-Vessel Recanalization at 36 Hours
Target-vessel recanalization will be assessed on CT angiography or MR angiography by the blinded central imaging core laboratory according to the prespecified imaging criterion.
Change in Infarct Volume From Baseline to Day 7 or Discharge
Change in infarct volume will be calculated as the follow-up infarct volume minus the baseline ischemic core volume, measured in milliliters by the blinded central imaging core laboratory using validated automated imaging software. Positive values indicate infarct growth.
Distribution of mRS Scores at Day 7 or Discharge
Distribution of modified Rankin Scale scores across all categories from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
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