The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System

Condition(s) studied

Investigational drug(s) / intervention(s)

liac Bifurcation Stent Graft System: to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA)

Study summary

The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).

Eligibility

Primary outcome measure(s)

• The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively. — within 30 Days postoperatively
  Major Adverse Events (MAE) are defined as follows: all-cause mortality related to iliac artery aneurysms associated with the surgery or device, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
• he patency rate of internal iliac artery (IIA) at 12 months postoperatively — at 12 months postoperatively
  The patency rate of internal iliac artery (IIA) defined as blood flow without occlusion maintained through the device without intervention

Trial sites (1)

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