Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Rate of symptomatic intracranial hemorrhage
研究概览
简要总结
- To evaluate whether stent implantation on the ipsilateral extracranial segment, after intracranial thrombectomy successful recanalization compared with balloon angioplasty (eTICI≥2b_50) for acute anterior circulation tandem lesions within 24h of onset, can improve neurological functional outcomes(mRS≤2).
- To evaluate whether stent implantation on the ipsilateral extracranial segment, after intracranial thrombectomy successful recanalization compared with balloon angioplasty (eTICI≥2b_50) for acute anterior circulation tandem lesions within 24h of onset, can increase the risk of symptomatic intracranial hemorrhage.
详细描述
The study was a prospective, randomized, open-label, blinded end-point Clinical Trial.
Subjects were randomized 1:1 according to inclusion and exclusion criteria into a trial group (acute phase extracranial vascular stent implantation group) and a control group (acute phase non-extracranial vascular stent implantation group). Randomization was performed for 90d and 180d for the follow-up to collect primary and secondary efficacy and safety indicators.
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
- Randomization results are known only to the patients themselves and the treating physicians. Baseline and in-hospital visits related to the study endpoint should be evaluated by a third party who is unknown to the patients' grouping and actual treatment status.2. Visits to the primary endpoint were conducted by trained third-party personnel. Standardized visits were conducted under the premise of unknown patient randomization and actual treatment status, and follow-up reports were prepared.3. All research-related image data will be collected for centralized interpretation. The images at each site were interpreted independently, and the readers were not aware of the patient's baseline condition, treatment received (except the images during baseline surgical treatment), and prognosis.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfy one of the following criteria:①Within 6 hours of onset, imaging confirmed occlusion of the acute anterior circulation internal carotid artery or the M1 / M2 segment of the middle cerebral artery；②Within 6-16 hours of onset, imaging confirmed acute occlusion of anterior circulation internal carotid artery or M1 / M2 segment of middle cerebral artery followed by DAWN or DEFUSE-3 criteria；③In patients with 16 to 24 hours of onset, imaging confirmed intracranial occlusion of the acute anterior circulation internal carotid artery or M1 / M2 segment of the middle cerebral artery followed by DAWN criteria.
- •Extracranial segment stenosis ≥70% or occlusion in tandem lesions.
- •ASPECT score ≥ 6 points.
- •eTICI≥2b_50 after middle cerebral artery thrombectomy and extracranial balloon dilatation in 10min.
排除标准
- •Participating in other clinical trials; 2.It is planned to carry out selective internal carotid artery stent implantation within 3 months; 3.Intracranial hemorrhage, subarachnoid hemorrhage within 3 months; previous brain tumor (with space-occupying effect).
- •4.Parenchymal organ surgery or biopsy were performed last 1 month; Any active or recent bleeding (gastrointestinal, urinary, etc.); Parenchymal organ surgery and biopsy were performed last 1 month 5.Difficult to control hypertension: systolic blood pressure> 185mmHg and/ or diastolic blood pressure> 110mmHg.
- •6.Severe active bleeding or known significant bleeding tendency: platelet count <100X109/L; heparin within 48 hours before surgery, and APTT≥35s; oral warfarin, and INR> 1.7; direct thrombin or factor Xa inhibitors, such as apixaban tablets, rivaroxaban tablets and dabigatran (patients with no history of abnormal coagulation or suspected abnormal coagulation function do not need laboratory results of INR or APTT before enrollment）.
- •7.Severe heart, liver, kidney, and other organ insufficiencies (glomerular filtration rate <30 ml/min or blood creatinine> 220μmol/L(2.5mg/dl)).
- •8.Patients occurred acute ischemic cerebral infarction within 48 hours after percutaneous coronary or cerebrovascular intervention or major surgery (if more than 48h, patients may be enrolled).
- •The patient has a history of cerebral vasculitis with clear evidence;
- •Patients with pre-onset neurological or psychiatric disorders that affect the assessment of their condition 11.Women who are known to be pregnant or lactating. 12.Known severe allergy to contrast agents (except for mild rash allergy) 13.Expected survival time less than 1 year (such as combined malignancy, severe cardiopulmonary disease, etc.) 14.Patients unable to complete the follow up (e. g., no fixed residence, overseas patients, etc.).
- •Imaging exclusion criterias:
- •Imaging confirmed the posterior circulatory lesions.
- •Midline displacement of the brain or brain herniation, ventricular occupancy
- •New onset bilateral acute stroke or multiple intracranial macrovascular occlusions.
- •Patients with vascular variants that are difficult to treat with endovascular therapy as displayed by CTA/MRA;
- •The ipsilateral middle cerebral artery and anterior cerebral occlusion were combined.
研究组 & 干预措施
Thrombectomy + Carotid Stenting
After emergency admission,intravenous thrombolysis will be administered if possible. Standard endovascular thrombectomy (EMT) and balloon angioplasty will be performed. The method of EMT and the order of endovascular treatment were selected by each center. After EMT and balloon angioplasty, patients with eTICI≥2b_50 were maintained for more than 10 minutes for randomization. In the intervention arm, emergent carotid stenting will be performed. Standardized treatment with antiplatelet and other drugs will be given. A loading dose of antiplatelet agents (aspirin 300 mg and clopidogrel 300 mg) or Tirofiban was given as an intraoperative drug treatment to endovascular therapy prior to emergency balloon dilation or stenting. Intravenous sedation or general anesthesia will be permitted.
Oral dual antiplatelet treatment for more than 1 month. Tirofiban is maintained for 24-48 hours, overlapping with oral antiplatelet for 4-6 hours, after excluding intracranial hemorrhage.
干预措施: Carotid Stenting (Device)
Thrombectomy + Carotid Stenting
After emergency admission,intravenous thrombolysis will be administered if possible. Standard endovascular thrombectomy (EMT) and balloon angioplasty will be performed. The method of EMT and the order of endovascular treatment were selected by each center. After EMT and balloon angioplasty, patients with eTICI≥2b_50 were maintained for more than 10 minutes for randomization. In the intervention arm, emergent carotid stenting will be performed. Standardized treatment with antiplatelet and other drugs will be given. A loading dose of antiplatelet agents (aspirin 300 mg and clopidogrel 300 mg) or Tirofiban was given as an intraoperative drug treatment to endovascular therapy prior to emergency balloon dilation or stenting. Intravenous sedation or general anesthesia will be permitted.
Oral dual antiplatelet treatment for more than 1 month. Tirofiban is maintained for 24-48 hours, overlapping with oral antiplatelet for 4-6 hours, after excluding intracranial hemorrhage.
干预措施: Thrombectomy (Procedure)
Thrombectomy + Carotid Stenting
After emergency admission,intravenous thrombolysis will be administered if possible. Standard endovascular thrombectomy (EMT) and balloon angioplasty will be performed. The method of EMT and the order of endovascular treatment were selected by each center. After EMT and balloon angioplasty, patients with eTICI≥2b_50 were maintained for more than 10 minutes for randomization. In the intervention arm, emergent carotid stenting will be performed. Standardized treatment with antiplatelet and other drugs will be given. A loading dose of antiplatelet agents (aspirin 300 mg and clopidogrel 300 mg) or Tirofiban was given as an intraoperative drug treatment to endovascular therapy prior to emergency balloon dilation or stenting. Intravenous sedation or general anesthesia will be permitted.
Oral dual antiplatelet treatment for more than 1 month. Tirofiban is maintained for 24-48 hours, overlapping with oral antiplatelet for 4-6 hours, after excluding intracranial hemorrhage.
干预措施: Dual antiplatelet treatment (Drug)
Thrombectomy + Carotid Stenting
After emergency admission,intravenous thrombolysis will be administered if possible. Standard endovascular thrombectomy (EMT) and balloon angioplasty will be performed. The method of EMT and the order of endovascular treatment were selected by each center. After EMT and balloon angioplasty, patients with eTICI≥2b_50 were maintained for more than 10 minutes for randomization. In the intervention arm, emergent carotid stenting will be performed. Standardized treatment with antiplatelet and other drugs will be given. A loading dose of antiplatelet agents (aspirin 300 mg and clopidogrel 300 mg) or Tirofiban was given as an intraoperative drug treatment to endovascular therapy prior to emergency balloon dilation or stenting. Intravenous sedation or general anesthesia will be permitted.
Oral dual antiplatelet treatment for more than 1 month. Tirofiban is maintained for 24-48 hours, overlapping with oral antiplatelet for 4-6 hours, after excluding intracranial hemorrhage.
干预措施: Intraoperative Drug Treatment (Drug)
结局指标
主要结局
Rate of symptomatic intracranial hemorrhage
时间窗: at 36 hours (±12 hours)
Rate of symptomatic intracerebral hemorrhage at CT (Computerized Tomography) or MRI (Magnetic Resonance Imaging) at 36 hours (±12 hours) according to the Heidelberg classification (independent imaging core laboratory).
Rate of functional independence
时间窗: at 90±7 days
Rate of functional independence defined as a modified Rankin Scale (mRS) score 0-2 at 90 (±7 days) (blind and independent evaluation) The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.
次要结局
- The NIHSS score(at 5-7days or discharge)
- The mRS scores(at 90±7days and 180±14 days)
- All-cause mortality(at 90±7days)
- Rate of carotid stenosis(at 5-7days or discharge)
- The incidence of serious adverse events.(at 90±7days and 180±14 days)
- The National Institutes of Health Stroke Scale (NIHSS) score(at 36 hours (±12 hours))
- The incidence of adverse events.(at 90±7days and 180±14 days)
- The expanded treatment in cerebral infarction (eTICI) score(at the end of the endovascular procedure)
- Rate of asymptomatic intracranial hemorrhage(at 36 hours (±12 hours))
- Ipsilateral carotid residual stenosis rate(at the end of the endovascular procedure)
- Proportion of NIHSS scores 0-1(at 36 hours (±12 hours))
- Change in National Institutes of Health Stroke Scale (NIHSS) score(at 36 hours (±12 hours))
- Proportion of mRS score 0-3(at 90±7days and 180±14 days)
研究者
Xueli Cai
Chief physician
Lishui Municipal Central Hospital