Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Trial Parameters
Brief Summary
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
Eligibility Criteria
Inclusion Criteria: Female and male subjects age ≥ 18 2. Subject need to meet one of the following criteria: * Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoracoabdominal aneurysm of diameter \>5.5cm (male) and 5.2cm (female) * Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoraco-abdominal aneurysm with aneurysm growth rate ≥ 0.5cm during 6 months * Type IA endoleak of post-implantation of abdominal stent- graft 3. Iliac arteries morphology with aortic stent graft implantation to be restored 4. Aortic segment which is proximal to aneurysm * Length ≥20mm * Diameter 20mm-36mm * Aortic suprarenal angle ≤75 degrees 5. Survival \> 2 years Exclusion Criteria: 1. Female and male subjects age \<18 2. Pregnancy and breast feeding 3. Allergy and hypersensitivity to matherials of which the stent- graft is composed 4. Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated