Status:
COMPLETED
Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Aortic Dissection Type B
Eligibility:
All Genders
18+ years
Phase:
NA
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 Sta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 .
Key Trial Info
Start Date :
November 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04918212
Start Date
November 25 2017
End Date
October 13 2020
Last Update
November 8 2021
Active Locations (24)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, China
2
Chinese People's Liberation Army General Hospital
Beijing, China
3
Peking University People's Hospital
Beijing, China
4
Xiangya Hospital of Central South University
Changsha, China