Clinical trial NCT04918212: Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
Official title: Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection: A Prospective, Multi-center, Single Arm, Objective Performance Criteria Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Dissection Type B
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥18 years old;
2. The informed consent was signed by the patient or the legal representative;
3. Diagnosed with Stanford B aortic dissection;
4. The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
5. Has a suitable arterial approach and is suitable for surgical treatment.

Exclusion Criteria:

1. The patient's distal vascular false cavity has been completely thrombotic or organized;
2. Pregnant or breastfeeding ;
3. Has participated in clinical trials of other devices ；
4. History of aortic surgery or endovascular repair surgery ;
5. Allergic to contrast agents and anesthetics ;
6. Allergic to stents or conveyors ;
7. Patients with true or false aortic aneurysm;
8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
9. Life expectancy is less than 12 months;
10. Other situations in which the investigator judges that not suitable for endovascular treatment .

Primary outcomes:
measure: Number of patients with no incidence of major surgical or device related adverse events rate
timeFrame: within 30 days after surgery
measure: Clinical success rate
timeFrame: 12 months after surgery
Secondary outcomes:
measure: adverse event rate
timeFrame: within 12 months after surgery
measure: Immediate delivery success rate
timeFrame: immediately after the surgery
measure: Immediate operation successful rate
timeFrame: immediately after the surgery
measure: Endoleak rate
timeFrame: within 12 months after surgery
measure: Secondary surgical treatment rate
timeFrame: within 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Haikou
country: China
facility: Hainan Provincial People's Hospital
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical College
city: Liuzhou
country: China
facility: Liuzhou Workers' Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
city: Shijia Zhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of the Fourth Military Medical University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: