Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Proportion of patients with mRS 0-2
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and treating interventionists will be aware of treatment allocation. Clinical outcome assessors, personnel conducting the 90-day follow-up, and central imaging core laboratory readers will remain blinded to treatment allocation and the treatment actually received. Imaging outcomes will be assessed independently using centralized blinded evaluation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Pre-stroke modified Rankin Scale (mRS) score of 0-
- •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
- •Baseline Alberta Stroke Program Early CT Score (ASPECTS) of at least 6 for anterior-circulation stroke, or posterior-circulation ASPECTS (pc-ASPECTS) of at least 6 for posterior-circulation stroke.
- •Occlusion of the intracranial internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery.
- •The clinical care team plans to perform endovascular treatment.
- •The participant or the participant's legally authorized representative is able to provide written informed consent.
- •Baseline CT perfusion or MR perfusion imaging demonstrating an ischemic core volume of less than 70 mL, a mismatch ratio of at least 1.2, and a mismatch volume of at least 15 mL.
- •Intracranial atherosclerosis is considered the underlying etiology, with residual stenosis of at least 50% after endovascular treatment, and rescue balloon angioplasty or stenting is planned
排除标准
- •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.
- •Contraindication to iodinated contrast agents, nickel, titanium, or their alloys.
- •Life expectancy of less than 6 months.
- •Pre-existing neurological or psychiatric disease that may confound neurological or functional outcome assessment.
- •Severe renal impairment, defined as glomerular filtration rate below 30 mL/min or serum creatinine above 220 μmol/L (2.5 mg/dL).
- •Arterial tortuosity or another arterial condition that would prevent the study device from reaching the target vessel.
- •Unlikely to complete the 90-day follow-up.
- •Any definite cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, history of atrial or ventricular thrombus, myocardial infarction within the preceding 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, or left ventricular ejection fraction below 30%.
- •Use of any glycoprotein IIb/IIIa inhibitor other than tirofiban.
研究组 & 干预措施
Experimental: Rescue Balloon Angioplasty Group
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.
干预措施: balloon angioplasty (Procedure)
Active Comparator: Rescue Intracranial Stenting Group
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.
干预措施: Stent (Procedure)
结局指标
主要结局
Proportion of patients with mRS 0-2
时间窗: 90 days after randomization (±7 days)
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.
次要结局
- Change in NIHSS Score From Baseline to 36 Hours(36 hours after randomization (±12 hours))
- Proportion of Participants With Target-Vessel Recanalization at 36 Hours(36 hours after randomization (±12 hours))
- Change in Infarct Volume From Baseline to Day 7 or Discharge(7 days after randomization (±1 day) or at discharge, whichever occurs first)
- Distribution of mRS Scores at Day 7 or Discharge(7 days after randomization or at discharge, whichever occurs first)
- Distribution of mRS Scores at 90 Days(90 days after randomization (±7 days))
- Proportion of Participants Achieving an Excellent Functional Outcome at 90 Days(90 days after randomization (±7 days))
- Proportion of Participants With an mRS Score of 0-3 at 90 Days(90 days after randomization (±7 days))
- Proportion of Participants Requiring Additional Pharmacologic Rescue Therapy(Within 90 days after randomization)
- Proportion of Participants Requiring Additional Procedural Rescue Treatment(Within 90 days after randomization)
- EQ-5D-5L Index Score at 90 Days(90 days after randomization (±7 days))
- Symptomatic Intracranial Hemorrhage Within 48 Hours(Within 48 hours after randomization)
- All-Cause Mortality at 90 Days(Within 90 days after randomization (assessment window ±7 days))
- Any Intracranial Hemorrhage Within 48 Hours(Within 48 hours after randomization)