Study of Endovascular Repair for Complex Thoracoabdominal and Aortic Arch Aneurysms Using Custom and Off-the-Shelf Branched and Fenestrated Stent Grafts

What this Trial Is About

Researchers are evaluating the feasibility, safety, and clinical outcomes of endovascular repair for complex aortic aneurysms, including thoracoabdominal aortic aneurysms TAAA and aortic arch aneurysms. This study focuses on patients considered high risk for open surgery and compares two approaches within two study arms one for TAAA and one for aortic arch aneurysms. The goal is to assess how well these minimally invasive techniques work in managing these serious aneurysms. The study involves implanting specialized stent graft devices tailored to each aneurysm type. In the TAAA arm, either a standard Off-the-Shelf multibranched stent graft or a custom-made physician-specified branched and fenestrated stent graft is used. These devices are designed to maintain blood flow to vital arteries supplying the liver, stomach, intestines, and kidneys. In the aortic arch arm, customized stent grafts with up to three branches or a retrograde left subclavian branch stent-graft with wide scallops are implanted to treat aneurysms involving the aortic arch and its branches. Participants will undergo pre-treatment assessments and receive the endovascular repair procedure. They will be followed closely with evaluations including technical and procedural success during and after the operation, and monitoring for aneurysm-related mortality and treatment success up to one year. Further yearly assessments for up to five years will check artery patency, survival, complications, and stent graft performance. The entire involvement ensures ongoing safety monitoring and evaluation of long-term outcomes after the procedure.

Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts