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

Not Applicable

Completed

• Conditions: Aortic Dissection Type B

• 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

Study Timeline

• Study Start: 2017-11-25
• Primary Completion: 2020-10-13
• Study Completion: 2020-10-13
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

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

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