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RecruitingPhase 2Phase 3NCT06969729

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

Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial

Sponsor

Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

Enrollment

100 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Abdominal Aortic AneurysmEndoleakJuxtarenal Aortic AneurysmThoracoabdominal Aneurysm

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria18

  • 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
  • Coagulopathy which cannot medically treated
  • Active infection which might cause stent - graft infection
  • Creatinine level \> 3.0mg/dL
  • Marphan syndrome, Ehlers - Denlos syndrome
  • Unstable angina pectoris
  • Raptured aortic aneurysm caused by cardiac insufficiency
  • Unwillingness to comply with protocol procedures
  • Iliac arteries morphology adequate for stent-graft implantation
  • The diameter of the aortic flow lumen in reno-visceral aorta greater than 34mm
  • Aortic section which is proximal to celiac artery with significant number of thrombi, calcification or changed by aneurysm
  • Aorta with significant number of irregular thrombi which may lead to embolism ("shaggy aorta")
  • Diameter of proximal kidney arteries which is exercisable to stenting \<4.5mm
  • Devision of kidney artery which is exercisable to stenting in the distance of \<1cm of celiac artery, each of them is is in \<4.5mm in diameter
  • Atypical anatomy of celiac artery in the form of separate exit of splenic and hepatic aortic artery
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Interventions

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

Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.

Locations(1)

An Independent Clinical Hospital 2 PUM

Szczecin, West Pomeranian Voivodeship, Poland

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NCT06969729

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