Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System

The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.

Inclusion criteria

• Patients aged 18 to 85 years old；
• Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;
• The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)；
• Ascending aorta diameter ≥24mm and ≤44mm；
• The diameter of the iliac artery ≥7mm ；
• The diameter of the innominate artery ≤24mm, and the length ≥20mm；
• Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.

Exclusion criteria

• Patients with ascending aortic aneurysm, dissection, ulcer, hematoma；
• Experienced systemic infection during past three months;
• History of aortic valve repair or replacement；
• History of aortic surgery or endovascular repair surgery；
• Carotid artery is severely narrowed, calcified, clotted, twisted；
• Right axillary artery is severely narrowed, calcified, thrombosis, twisted；
• Heart transplant；
• Suffered MI or stroke during past three months；
• Class IV heart function (NYHA classification)；
• Pregnant or breastfeeding；
• Allergies to contrast agents；
• Life expectancy less than 12 months。