NCT05496361已完成不适用
A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
Suzhou Zenith Vascular Scitech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2021年1月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
研究概览
简要总结
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.
详细描述
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-85 years
- •within 8 hours after symptom onset
- •The results showed that the scores of ASPECTS ≥6, 0<NIHSS<30 , and mRS <2 ;
- •caused by a large vessel occlusion of the anterior circulation (internal carotid artery or the M1 and M2 segments of MCA and the A1 and A2 segments) cerebral artery confirmed by DSA;
- •Signed informed consent.
排除标准
- •Clinical exclusion criteria:
- •Patients with epileptic seizure during stroke;
- •Patients with life expectancy less than 90 days;
- •Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months;
- •Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment
- •Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months;
- •Patients with gastrointestinal or urinary tract bleeding in the past three weeks;
- •Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn from the group within the first one months of the screening period of this trial;
- •Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases;
- •Patients with active bleeding or known bleeding tendency (INR>3.0 or platelet count<40*10^9/L or APTT>50 seconds);
- •The blood glucose which could not be controlled by drugs was less than 2.7 mmol/L or more than 22.2 mmol/L;
- •Patients with hypertension beyond the control of drugs (systolic blood pressure >180 mmHg, or diastolic blood pressure >105 mmHg);
- •Females who are pregnant or in lactation;
- •Patients who are known to be allergic or resistant to contrast agents, anesthetics, anticoagulants, antiplatelet drugs and nickel-titanium;
- •Patients who have undergone major surgical operations in the past month;
- •Other cases with unknown onset time or unsuitable for inclusion in the group judged by researchers;other conditions not suitable for inclusion judged by the researcher;
- •Imaging exclusion criteria
- •Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator);
- •ASPECTS <6 points on head CT;
- •Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion;
- •DSA showed that bilateral carotid system was occluded at the same time;
- •DSA showed (or highly suspected) carotid dissection or arteritis;
- •DSA showed that the vascular route was tortuous, and the device was difficult to reach the target position or recover;
- •Subjects who are not eligible for inclusion after imaging review in the group judged by researchers.
结局指标
主要结局
Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
时间窗: At immediate post-procedure
次要结局
- Times to revascularization（From groin puncture to final revascularization result）(At immediate post-procedure)
- NIHSS score at 24h, 7-day or discharge(Within 24 hours，7-day or discharge post-procedure, whichever came first)
- Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2(at 90 days post-procedure)
- Device Technical Success(At immediate post-procedure)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese AdultsNasolabial FoldsNCT06367634Teoxane SA390
进行中（未招募）
不适用
Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery DiseasePrimary Valvular Heart Disease With Comorbid Coronary Artery DiseasePlanned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart DiseaseNCT03977129Ruijin Hospital792
已完成
不适用
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUsChronic UlcerDiabetic FootNCT04185558RedDress Ltd.119
已完成
不适用
A Clinical Study of Chinese Domestic Surgical RobotGallstoneCholecystitisNCT04122261The Third Xiangya Hospital of Central South University168
已完成
不适用
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic StrokeAcute Ischemic Stroke From Large Vessel OcclusionNCT01584609Penumbra Inc.198