Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction

Inclusion criteria

• Aged 18 to 80 years
• Diagnosed with aortic arch pathology requiring intervention, including:

True aortic arch aneurysm

Pseudoaneurysm of the aortic arch

Penetrating aortic ulcer involving the arch

• Deemed suitable for endovascular repair by the investigating physician
• Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements
• Anatomic suitability confirmed by CTA:

Ascending aortic length ≥50 mm

Ascending aortic diameter ≥26 mm and ≤46 mm

Proximal landing zone length ≥20 mm

Brachiocephalic trunk diameter ≥9 mm and ≤19 mm with length ≥20 mm

Left common carotid artery (LCCA) and left subclavian artery (LSA) diameters ≥5 mm and ≤13 mm

LCCA length ≥20 mm

Distance from LSA ostium to left vertebral artery origin ≥20 mm

• High surgical risk per investigator assessment OR contraindicated for open surgery

Exclusion criteria

• 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
• Documented allergy to nitinol, contrast media, or device materials
• Severe renal impairment:(Serum creatinine >2×ULN,Excluding dialysis-dependent patients)
• Hematologic abnormalities:(WBC <3×10⁹/L、Hb <70 g/L、PLT <50×10⁹/L)
• Heart transplant recipients
• Myocardial infarction or stroke within 3 months
• NYHA Class IV heart failure
• Active systemic infection (e.g., bacteremia, sepsis)
• Life expectancy <12 months
• Mechanical aortic valve prosthesis impeding device delivery
• Current participation in other interventional trials with primary endpoint pending
• Anticipated poor compliance with follow-up
• Other contraindications for endovascular repair per investigator assessment:Severe vascular stenosis/calcification/tortuosity/Thrombus at landing zones/Inability to cooperate with procedure