A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fabulous Thoracic Aortic Stent System
|
Device: Fabulous Thoracic Aortic Stent System
Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System
|
Outcome Measures
Primary Outcome Measures
- Major adverse events [within 30 days after operation]
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.
Secondary Outcome Measures
- Immediate technical success [Immediate during operation]
Immediate technical success was defined as the stent was successfully delivered to the intended site and released.
- Change of diameter [30 days, 3 months,6 months after operation]
Changes of minimum diameter of true lumen, maximum diameter of false lumen and maximum total diameter of aorta before and after operation.
- Major adverse events [3 months,6 months after operation]
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.
- All-cause death and dissection related death [3 months,6 months after operation]
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.
- The incidence of reintervention [30 days, 3 months,6 months after operation]
Thoracotomy or secondary intervention due to aortic dissection
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years old, regardless of gender;
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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;
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With appropriate arterial access and suitable for endovascular aortic repair;
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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:
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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;
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Patients were unable or unwilling to participate in the study;
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Patients were judged by the investigator to be ineligible for participation in the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital Of Harbin Medical University | Harbin | Heilongjiang | China | |
| 2 | Wuhan Asia General Hospital | Wuhan | Hubei | China | |
| 3 | Central Hospital of Dalian University of Technology | Dalian | Liaoning | China | |
| 4 | The First People's Hospital of Yunnan Province | Kunming | Yunnan | China | |
| 5 | Beijing Anzhen Hospital, Capital Medical University | Beijing | China | ||
| 6 | Fu Weiguo | Shanghai | China | ||
| 7 | Shanghai Chest Hospital | Shanghai | China |
Sponsors and Collaborators
- Hangzhou Endonom Medtech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Fabulous WQ-F02