Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
- Conditions
- Aortic Dissection Type B
- Interventions
- Device: Fabulous Stent Graft System
- Registration Number
- NCT04918212
- Lead Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Brief Summary
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- Patients ≥18 years old;
- The informed consent was signed by the patient or the legal representative;
- Diagnosed with Stanford B aortic dissection;
- The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
- Has a suitable arterial approach and is suitable for surgical treatment.
- The patient's distal vascular false cavity has been completely thrombotic or organized;
- Pregnant or breastfeeding ;
- Has participated in clinical trials of other devices ；
- History of aortic surgery or endovascular repair surgery ;
- Allergic to contrast agents and anesthetics ;
- Allergic to stents or conveyors ;
- Patients with true or false aortic aneurysm;
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- Life expectancy is less than 12 months;
- Other situations in which the investigator judges that not suitable for endovascular treatment .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fabulous Stent Graft System Fabulous Stent Graft System All patients received endovascular surgery using fabulous stent graft system
- Primary Outcome Measures
Name Time Method Number of patients with no incidence of major surgical or device related adverse events rate within 30 days after surgery Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device
Clinical success rate 12 months after surgery Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection
- Secondary Outcome Measures
Name Time Method Endoleak rate within 12 months after surgery adverse event rate within 12 months after surgery Immediate operation successful rate immediately after the surgery After the operation, angiographic observation showed that the proximal covered stent was in an appropriate position and adhered well without obvious endoleak, while the distal bare stent was in an appropriate position and adhered well
Immediate delivery success rate immediately after the surgery The stent graft system was successfully transported to the correct position and released successfully
Secondary surgical treatment rate within 12 months after surgery Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation
Trial Locations
- Locations (24)
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Chinese People's Liberation Army General Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, China
Hainan Provincial People's Hospital
🇨🇳Haikou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
The First Affiliated Hospital of Kunming Medical College
🇨🇳Kunming, China
Liuzhou Workers' Hospital
🇨🇳Liuzhou, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, China
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Jiangsu Provincial People's Hospital
🇨🇳Nanjing, China
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
The First Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of the Fourth Military Medical University
🇨🇳Xi'an, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Xiangya Hospital of Central South University
🇨🇳Changsha, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China