Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion: A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Proportion of patients with mRS 0-2
研究概览
简要总结
The primary objective of this study is to evaluate whether rescue stenting therapy can improve neurological functional outcomes after failed endovascular treatment for acute ischemic stroke caused by large vessel occlusion. The study population is divided into two groups:
Stent Placement Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed.
Continued Thrombectomy Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed.
The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90±7 days.
The safety endpoint is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization.
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)
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
- •Pre-stroke mRS 0-1
- •Symptoms of AIS present within 24 hours of last known well time
- •Baseline NIHSS score ≥6
- •Anterior circulation: ASPECTS ≥6; Posterior circulation: pc-ASPECTS ≥6
- •Occlusion of intracranial ICA, M1 segment of MCA, V4 segment of vertebral artery, or basilar artery
- •Clinical care team intends to perform endovascular therapy (EVT)
- •Failure to achieve recanalization (eTICI 0-1) after 3 thrombectomy attempts, including: At least one contact aspiration attempt; At least one stent retriever attempt or combined approach
- •Subject or legally authorized representative can provide informed consent
排除标准
- •Intracranial hemorrhage confirmed by imaging prior to randomization; or intraprocedural flat-panel CT evidence of major hemorrhage
- •Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset; or major surgery within 14 days
- •Bleeding diathesis, including:Laboratory evidence of coagulopathy (PLT <100×10⁹/L, aPTT >50 sec, or INR >2.0); Direct oral anticoagulant (DOAC) use within 48 hours prior; History of heparin-induced thrombocytopenia (HIT)
- •Pregnancy or lactation at admission
- •Contraindications to:Radiographic contrast agents; Nickel, titanium, or their alloys (device-related)
- •Life expectancy <6 months
- •Pre-existing neurological/psychiatric conditions that may confound neurological assessment
- •Severe renal insufficiency:GFR <30 mL/min or Serum creatinine >220 μmol/L (2.5 mg/dL)
- •Arterial tortuosity or other vascular anomalies preventing device delivery to target vessel
- •Unlikely to complete 90-day follow-up
结局指标
主要结局
Proportion of patients with mRS 0-2
时间窗: 90±7 days
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
次要结局
- Incidence of rescue therapy(90±7 days)
- EQ-5D-5L utility score(90±7 days)
- Probability of any intracranial hemorrhage (per Heidelberg criteria)(48 hours post-randomization)
- Change in NIHSS score from baseline(36±12 hours post-randomization)
- Vascular recanalization rate assessed by CT/MR angiography(at 36±12 hours post-randomization)
- Change in infarct volume(at 7±3 days post-randomization or discharge (whichever comes first))
- Distribution of mRS scores(7±3 days/discharge and 90±7 days post-randomization)
- Proportion of patients achieving mRS 0-1(90±7 days)
- Probability of symptomatic intracranial hemorrhage(48 hours)
- All-cause mortality(90±7 days post-randomization)