Endovascular Repair of Stanford B-type Thoracic Aortic Dissection With Insufficient Proximal Landing Zone by Left Subclavian Artery in Situ Stent Graft Puncture and Fenestration: A Prospective, Single-arm, Observational Clinical Trial.
Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. At present, the endovascular repair of the thoracic aorta (TEVAR) for AD has been widely deployed worldwide and has become the standard surgical procedure for the treatment of AD. However, there is still controversy regarding the Stanford B aortic dissection that involves the left subclavian artery or the stent landing area less than 1.5 cm. Study objective: To evaluate the effectiveness and safety of endovascular repair with in situ needle fenestration of left subclavian artery.
Methods: This study intends to enroll 217 patients with Stanford type B aortic dissection who meet the enrollment criteria. The patients will be followed up at 1, 6, 12, and 24 months after endovascular repair, and the CTA images of the thoracic aorta were collected.
• Based on Computed Tomography Angiography, it is clearly diagnosed as Stanford B type aortic dissection with a breach close to the left subclavian artery;
• The dissection the left subclavian artery, and the proximal landing area is less than 1.5cm. The proximal end of the stent needs to be anchored in zone 2 and the left subclavian needs to be performed arterial revascularization;
• Landing area requirements: no dissection, no intermural hematoma, no severe calcification, no aneurysm-like expansion, diameter 21-44mm, distance between left common carotid artery and left subclavian artery≥10mm;
• The puncture in situ fenestration technique was used to reconstruct the left subclavian artery;
• Signed informed consent;
• Age ≥18 years old, ≤85 years old, no gender limit.