Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
1 other identifier
interventional
148
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Typical duration for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2020
CompletedFirst Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedNovember 8, 2021
November 1, 2021
2.9 years
June 2, 2021
November 1, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with no incidence of major surgical or device related adverse events rate
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
within 30 days after surgery
Clinical success rate
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
12 months after surgery
Secondary Outcomes (5)
adverse event rate
within 12 months after surgery
Immediate delivery success rate
immediately after the surgery
Immediate operation successful rate
immediately after the surgery
Endoleak rate
within 12 months after surgery
Secondary surgical treatment rate
within 12 months after surgery
Study Arms (1)
Fabulous Stent Graft System
EXPERIMENTALAll patients received endovascular surgery using fabulous stent graft system
Interventions
All patients received endovascular surgery using fabulous stent graft system
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Chinese People's Liberation Army General Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Hainan Provincial People's Hospital
Haikou, China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 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
Liuchow, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Provincial People's Hospital
Nanjing, 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
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
Yantai Yuhuangding Hospital
Yantai, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 8, 2021
Study Start
November 25, 2017
Primary Completion
October 13, 2020
Study Completion
October 13, 2020
Last Updated
November 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share