This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).
Age: 18 to 80 years old;
Maximum diameter of TAAA is >50 mm;
TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
Definite symptoms associated with TAAA, such as abdominal pain and back pain.
Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
Patients with thoracoabdominal aortic dissection;
Patients with infected or mycotic thoracoabdominal aortic aneurysms;
Patients with systemic or local infections that may increase the risk of endovascular graft infection;
Single group
The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system
DeviceThe thoracoabdominal artery stent graft system is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries.
Treatment success rate
Treatment success is a composite index that should meet all of the following criteria: * Immediate technical success: refers to successful delivery of the delivery system to the intended location, successful deployment of the stent graft, withdrawal of the delivery system, with no type I/III endoleak) \[Timeframe: intraoperative\], * No TAAA-related secondary intervention (including secondary intervention due to aneurysm rupture, sustained enlargement, stent migration, type I/III endoleak, branch stenosis/occlusion) \[Timeframe: 12-month post operation\].
Incidence of major adverse events (MAEs): 30-day post operation
MAEs are defined as all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.
Incidence of perioperative delivery system-related complications
Include conversion to open surgery, hemorrhage, hematoma, and pseudoaneurysm of the atrial access.
All-cause mortality
All-cause death is defined as death from any cause during the follow-up period.
TAAA-related mortality
TAAA-related death is defined as death due to rupture of TAAA or surgical treatment of TAAA.
Incidence of serious adverse events (SAEs)
If staged reconstruction is performed because of the patient's condition, then the reconstruction should not be a serious adverse event.
Click on the lead sponsor to view all of their trials.
