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

Hangzhou Endonom Medtech

Status: Completed

Conditions: Aortic Dissection Type B

Treatments: Device: Fabulous Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04918212

WQ1601

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

Fabulous Stent Graft System

Experimental group

Description:

All patients received endovascular surgery using fabulous stent graft system

Treatment:

Device: Fabulous Stent Graft System