Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)

This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system in the treatment of Stanford type B dissection of the proximal left subclavian artery. It is expected to complete the implantation of 120 patients in 29 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.

Inclusion criteria

• Patients aged 18 to 80 years old, no gender limitation;
• Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
• Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
• The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18～42mm;
• The length of the proximal anchoring area (the distance from the rear edge of the left common carotid artery opening to the first breach) ≥15mm;
• The distance between the left common carotid artery and the left subclavian artery ≥5mm;
• The distance between the left vertebral artery and the opening of the left subclavian artery is ≥15mm, the diameter of the starting part of the left subclavian artery is 6～20mm
• With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.

Exclusion criteria

• Pregnant, breastfeeding or cannot contraception during the trial period;
• Participated in clinical trials of other drugs or devices during the same period;
• The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
• Allergic to contrast agents, anesthetics, patches, and delivery materials;
• Cannot tolerate anesthesia;
• Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination];
• True/false thoracic aortic aneurysm
• History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
• Contraindications to antiplatelet drugs and anticoagulants
• Life expectancy is less than 12 months (such as advanced malignant tumors)
• Acute systemic infection
• Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent
• Investigator judged that not suitable for interventional treatment.