A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection

Study Overview
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Brief Summary
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A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.

Detailed Description
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Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.

Official Title
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A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection

Conditions
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Aortic Dissection

Intervention / Treatment
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* Device: Fabulous Thoracic Aortic Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old, regardless of gender; Subject was diagnosed with Stanford Type B dissection and treated with Fabulous thoracic aortic stent system, including either a covered stent system, a bare stent, or both; With appropriate arterial access and suitable for endovascular aortic repair; Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol. Exclusion Criteria: Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint; Patients were unable or unwilling to participate in the study; Patients were judged by the investigator to be ineligible for participation in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fabulous Thoracic Aortic Stent System<br> | Device: Fabulous Thoracic Aortic Stent System<br>* Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events | Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia. | within 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate technical success | Immediate technical success was defined as the stent was successfully delivered to the intended site and released. | Immediate during operation | 
| Change of diameter | Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation. | 30 days, 3 months,6 months after operation | 
| Major adverse events | Include all-cause death, aortic rupture, retrograde type A aortic dissection, distal stent graft induced new entry, endoleak, myocardial infarction, respiratory failure, renal failure, intestinal necrosis, permanent paraplegia, ischemic stroke, and severe lower limb ischemia. | 3 months,6 months after operation | 
| All-cause death and dissection related death | All-cause deaths are defined as death from any cause during the follow-up. Dissection related death refers to death caused by rupture of aortic dissection or endovascular treatment of aortic dissection. | 3 months,6 months after operation | 
| The incidence of reintervention | Thoracotomy or secondary intervention due to aortic dissection | 30 days, 3 months,6 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Dissection