Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection

Aortic Dissection Type B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918212
• Other study ID #: WQ1601
• Status: Completed
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: October 13, 2020

Study information

• Verified date: November 2021
• Source: Hangzhou Endonom Medtech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 13, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection Type B

Intervention

Device:
• Fabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system

Locations

Country	Name	City	State
China	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	Liuzhou
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

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Endonom Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	adverse event rate		within 12 months after surgery
Secondary	Immediate delivery success rate	The stent graft system was successfully transported to the correct position and released successfully	immediately after the surgery
Secondary	Immediate operation successful rate	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	immediately after the surgery
Secondary	Endoleak rate		within 12 months after surgery
Secondary	Secondary surgical treatment rate	Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation	within 12 months after surgery