An interventional study of Fabulous Stent Graft System in Aortic Dissection Type B, sponsored by Hangzhou Endonom Medtech Co., Ltd.. Completed at 24 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Hangzhou Endonom Medtech Co., Ltd. · Not applicable, Interventional, and Treatment
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.
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's enrollment of 148 is above the median of 84 across 198 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Hangzhou Endonom Medtech Co., Ltd. is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients received endovascular surgery using fabulous stent graft system
Device: Fabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system
Number of patients with no incidence of major surgical or device related adverse events rate
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
Time frame: within 30 days after surgery
Clinical success rate
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
Time frame: 12 months after surgery
adverse event rate
Time frame: within 12 months after surgery
Immediate delivery success rate
The stent graft system was successfully transported to the correct position and released successfully
Time frame: immediately after the surgery
Immediate operation successful rate
After the operation, angiographic observation showed that the proximal covered stent was in an appropriate position and adhered well without obvious endoleak, while the distal bare stent was in an appropriate position and adhered well
Time frame: immediately after the surgery
Endoleak rate
Time frame: within 12 months after surgery
Secondary surgical treatment rate
Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation
Time frame: within 12 months after surgery
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Hangzhou Endonom Medtech Co., Ltd.