An interventional study of balloon angioplasty and Stent in Acute Ischemic Stroke and Intracranial Atherosclerosis ICAS, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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
Exclusion Criteria:
Participants randomized to this group will undergo intracranial balloon angioplasty as the assigned initial rescue strategy for residual intracranial arterial stenosis after endovascular treatment. Bailout intracranial stenting is permitted if the angiographic result after balloon angioplasty is considered inadequate by the treating neurointerventionist according to the study protocol. Participants will receive periprocedural and postprocedural medical management according to the study protocol.
Procedure: balloon angioplasty
Participants randomized to this group will undergo intracranial stent implantation as the assigned rescue strategy for residual intracranial arterial stenosis after endovascular treatment. Balloon angioplasty may be performed before or after stent implantation when clinically indicated. Participants will receive periprocedural and postprocedural medical management according to the study protocol.
Procedure: Stent
Balloon angioplasty treatment followed by standard medical therapy post-procedure.
Patients 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.
Time frame: 90 days after randomization (±7 days)
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.
Time frame: 36 hours after randomization (±12 hours)
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.
Time frame: 36 hours after randomization (±12 hours)
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.
Time frame: 7 days after randomization (±1 day) or at discharge, whichever occurs first
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.
Time frame: 7 days after randomization or at discharge, whichever occurs first
Distribution of mRS Scores at 90 Days
Distribution of modified Rankin Scale scores across all categories from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Time frame: 90 days after randomization (±7 days)
Proportion of Participants Achieving an Excellent Functional Outcome at 90 Days
An excellent functional outcome is defined as a modified Rankin Scale score of 0-1. The mRS ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days after randomization (±7 days)
Proportion of Participants With an mRS Score of 0-3 at 90 Days
The outcome is defined as a modified Rankin Scale score of 0-3. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Time frame: 90 days after randomization (±7 days)
Proportion of Participants Requiring Additional Pharmacologic Rescue Therapy
Proportion of participants who receive additional pharmacologic rescue treatment for target-vessel reocclusion, restenosis, or related clinical deterioration after the randomized intervention. Protocol-mandated routine antiplatelet treatment will not be counted as pharmacologic rescue therapy.
Time frame: Within 90 days after randomization
Proportion of Participants Requiring Additional Procedural Rescue Treatment
Proportion of participants who undergo an additional endovascular or surgical rescue procedure because of target-vessel reocclusion, restenosis, or related clinical deterioration after the randomized intervention.
Time frame: Within 90 days after randomization
EQ-5D-5L Index Score at 90 Days
Health-related quality of life will be assessed using the EQ-5D-5L index score calculated with the prespecified Chinese value set. Scores range from -0.594 to 1.000, with higher scores indicating better health status.
Time frame: 90 days after randomization (±7 days)
Symptomatic Intracranial Hemorrhage Within 48 Hours
Symptomatic intracranial hemorrhage will be classified according to the Heidelberg Bleeding Classification and adjudicated by the blinded central imaging core laboratory and clinical event assessors.
Time frame: Within 48 hours after randomization
All-Cause Mortality at 90 Days
Proportion of participants who die from any cause within 90 days after randomization.
Time frame: Within 90 days after randomization (assessment window ±7 days)
Any Intracranial Hemorrhage Within 48 Hours
Any intracranial hemorrhage identified on follow-up CT or MRI and classified according to the Heidelberg Bleeding Classification, irrespective of the presence of neurological deterioration.
Time frame: Within 48 hours after randomization
Plan to share: No
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Beijing Anzhen Hospital