Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Intracranial Aneurysm
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 years, any gender; Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling; Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form. Exclusion Criteria: Aneurysm rupture within 30 days before enrollment; Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations; Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.); Modified Rankin Scale (mRS) score ≥3; Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.); Major surgery within 30 days before enrollment; Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy; Known allergy to nickel-titanium alloy metal materials; Life expectancy <12 months; Pregnant or breastfeeding women; Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent; Other conditions judged by the investigators as unsuitable for enrollment.
Sites / Locations
- The First Affiliated Hospital of Wannan Medical College
- Guangdong Provincial People's Hospital
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- Zhuhai People's Hospital
- Tongji Hospital Tongji Medical College of HUST
- Xiangya Hospital of Central South University
- General Hospital of Eastern Theater Command
- General Hospital of Northern Theater Command
- Qilu Hospital of Shandong University
- First Hospital of Shanxi Medical University
- Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
- The First Affiliated Hospital Zhejiang University School of Medicine
- The First Affiliated Hospital of Chongqing Medical University
- Changhai Hospital of Shanghai
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
experimental group
control group
Self-expanding Intracranial Stent (Tonbridge)
LVIS and LVIS Jr. (MicroVention)