An observational study in Aortic Dissection, sponsored by Hangzhou Endonom Medtech Co., Ltd.. Status unknown at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Hangzhou Endonom Medtech Co., Ltd. · Observational
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.
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 260 is above the median of 230 across 115 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Hangzhou Endonom Medtech Co., Ltd. is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Stanford type B aortic dissection are treated with Fabulous Thoracic Aortic Stent System in the real world.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Fabulous Thoracic Aortic Stent System
Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System
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.
Time frame: within 30 days after operation
Immediate technical success
Immediate technical success was defined as the stent was successfully delivered to the intended site and released.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months,6 months after operation
The incidence of reintervention
Thoracotomy or secondary intervention due to aortic dissection
Time frame: 30 days, 3 months,6 months after operation
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Hangzhou Endonom Medtech Co., Ltd.