A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with aortic arch pathologies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
The Thoracic Aortic Multi-Branch Stent Graft Systemm consists of the Single-Branch Aortic Stent-Graft System, the aortic extension stent graft system and the branch stent system.
Changhai Hospital
Shanghai, China
12-month treatment success rate
Technical success at the index procedure, without device- or aortic pathology-related mortality or unplanned secondary interventions, and with no evidence of persistent enlargement of the treated aortic segment due to Type I/III endoleaks on 12-month CTA follow-up.
Time frame: 12-month
30-day rate of Major Adverse Events (MAE)
Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure
Time frame: 30-day
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