Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSamodzielny Publiczny Szpital Kliniczny nr 2 PUM

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)

Treatment groups

100 Participants
are divided into 2 treatment groups