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.
Aged 18 to 80 years
Deemed suitable for endovascular repair by the investigating physician
Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements
High surgical risk per investigator assessment OR contraindicated for open surgery
Pregnant or lactating women
Connective tissue disorders affecting the aorta (e.g., Marfan syndrome, Ehlers-Danlos syndrome)
Infected aortic pathologies or aortitis (e.g., mycotic aneurysm, Takayasu arteritis)
Prior endovascular repair of ascending aorta/aortic arch
Single group
Thoracic Aortic Multi-Branch Stent Graft System
DeviceThe 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.
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.
30-day rate of Major Adverse Events (MAE)
Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure
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