NCT05898893招募中不适用
Prospective, Multi-Center, Open-Label, Single-Arm Registration Trial Of The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms
MicroPort NeuroTech Co., Ltd.8 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 8
- 主要终点
- Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures
研究概览
简要总结
A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old (as of the date of signing the informed consent form);
- •CTA, MRA or DSA angiography diagnosed as a large intracranial carotid artery or vertebral artery aneurysm (largest diameter of the aneurysm >= 10mm) or medium to small aneurysms (maximum diameter <10mm) (including saccular aneurysms and recurrent saccular aneurysms);
- •The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm < 2;
- •The diameter of the parent vessel is 2.0mm-6.5mm;
- •Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense mesh stent alone or in combination with coils;
- •Subjects are willing to follow up and evaluate according to the requirements of the clinical trial protocol;
- •The subjects or their guardians can understand the purpose of the trial, participate voluntarily and sign the informed consent.
排除标准
- •Aneurysm related to AVM and MMD;
- •Ruptured aneurysm within 30 days;
- •Multiple aneurysms;
- •Subjects with significant stenosis (stenosis rate >= 50%) or occlusion of parent artery
- •Recurrent aneurysms after stent or stent-assisted coil embolization;
- •Subjects with morphologies or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, Aortic dissection, restriction of vascular access (such as severe intracranial vascular tortuosity, severe intracranial vasospasm and no response to drug therapy, obstruction of device access due to other anatomical or clinical lesions);
- •Subjects who are not suitable for anesthesia or endovascular treatment, such as severe diseases of the heart, lung, liver, spleen, and kidney, brain tumors, severe active infection, disseminated intravascular coagulation, and a history of severe mental illness;
- •Subjects who underwent or plan undergo to major surgical operations (such as implantation of internal fixation devices for extremity fractures, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent form or 60 days after signing the informed consent form;
- •Modified Rankin score >= 4 points ;
- •The life expectancy of the subjects is less than 12 months;
- •Subjects who have participated in clinical trials of other drugs or medical devices before enrollment and did not reach the end point.
- •The researchers judged that the subjects had poor compliance and could not complete the study as required;
- •Subjects with suspected history of allergy to nickel-titanium, platinum, platinum-iridium alloys and other materials;
- •Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;
- •Subjects have or may have had a serious reaction to the contrast agent and could not complete the pre-treatment medication;
- •Women who are pregnant or breastfeeding;
- •Other conditions deemed inappropriate by the investigator to participate in the study.
结局指标
主要结局
Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures
时间窗: 6months±30 days
Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures
次要结局
- Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures(12months±60 days)
- Successful treatment（Raymond I or II）rate of aneurysm at 6 months after procedures(6months±30 days)
- Successful treatment（Raymond I or II）rate of aneurysm at 12 months after procedures(12months±60 days)
- Retreatment rate of target aneurysm during follow-up(12months±60 days)
- Success rate of stent implantation(Immediate evaluation after intervention)
- The proportion of subjects with ipsilateral stroke or neurogenic death to their target aneurysm at 1 month postoperatively, 6 months postoperatively, and 1 year postoperatively;(12months±60 days)
- The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures(6months±30 days)
- Proportion of subjects with complete in-stent occlusion within 6 months after procedures(6months±30 days)
- Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures(12months±60 days)
研究者
研究点 (8)
Loading locations...
相似试验
Unknown
不适用
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMSBrain DiseasesCardiovascular DiseasesAneurysmIntracranial AneurysmNCT05829746MicroPort NeuroTech Co., Ltd.65
已完成
不适用
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer PatientsRectal NeoplasmsNCT06204497Sir Run Run Shaw Hospital570
已完成
3 期
Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac ArteriesIntermittent ClaudicationAtherosclerotic DiseaseThrombosisArterial Occlusive DiseaseNCT00352222Boston Scientific Corporation150
已完成
3 期
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)Coronary DiseaseNCT00165035Cordis Corporation1,701
已完成
不适用
Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic DissectionAortic Dissection Type BNCT04918212Hangzhou Endonom Medtech Co., Ltd.148