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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Dissection Type B
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Enrollment
- 148
- Locations
- 24
- Primary Endpoint
- Number of patients with no incidence of major surgical or device related adverse events rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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 .
Outcomes
Primary Outcomes
Number of patients with no incidence of major surgical or device related adverse events rate
Time Frame: 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
Time Frame: 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 Outcomes
- Endoleak rate(within 12 months after surgery)
- adverse event rate(within 12 months after surgery)
- Immediate operation successful rate(immediately after the surgery)
- Immediate delivery success rate(immediately after the surgery)
- Secondary surgical treatment rate(within 12 months after surgery)