Distal Aortic Dissection Clinical Trial
Official title:
A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic
arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of
Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.
Number of patients: 70 patients will be included and undertaken endovascular repair with
Castor stent.
Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after
the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery
Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.
Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.
Other Outcome Measures:
1. efficacy:
- 1 year success rate of treatment
- 1 year patency rate of branch stent
2. safety:
- in-hospital mortality
- complication rate of neural system
- 1 year dissection or stent related mortality
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02622542 -
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
|
N/A |