the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
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
Female and male subjects age <18
Pregnancy and breast feeding
Allergy and hypersensitivity to matherials of which the stent- graft is composed
Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated medically
Parallel
Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)
Procedure/SurgeryImplantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.
Number of Participants Surviving at 1 Year Without Aortic Rupture
Rupture - free one year survival. The number of participants who remain alive and free from aortic rupture at 1 year following stent-graft implantation. Rupture will be defined as radiologically confirmed loss of aortic wall integrity with associated clinical symptoms.
Number of Participants Surviving at 30 Days Post-Procedure (Perioperative Survival)
The number of participants who are alive 30 days after the stent-graft procedure. Deaths from any cause within 30 days post-implantation will be counted.
Number of Deaths from Any Cause Within 1 Year
Total number of participant deaths due to any cause occurring within one year of the procedure.
Number of Cardiovascular-Related Deaths Within 1 Year
The number of participant deaths attributed to cardiovascular causes (e.g., myocardial infarction, stroke, aortic rupture) within 1 year of the procedure, as adjudicated by the study investigators.
Number of Participants Without Aneurysm Growth at 1 Year
The number of participants whose aneurysm size remains stable (no increase \>5 mm in maximum diameter) as assessed by imaging (e.g., CT angiography) at 1 year post-implantation.
Number of Participants Surviving Without Reintervention at 1 Year
The number of participants who do not require any secondary endovascular or surgical intervention related to the index aortic pathology within 1 year of the initial procedure.
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