A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch
1. Clinical trials using prospective, multi-center, single-group target value design; 2. 120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements. 3. CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device
Xiangya Second Hospital, Central South University
Changsha, Hunan, China
Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events(MAE) occurrence within 30 days after surgery
MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery
Time frame: Within 30 days after procedure
Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery
On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation
Time frame: 12 months after procedure
Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System
Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn
Time frame: intraoperative
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