Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Recruiting now · Not applicable
Conditions studied: Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Type IA Endoleak
In brief
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
Key facts
- Study ID
- NCT06969729
- Run by
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
- People needed
- 100
- Starts
- 2022-11-01
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- An Independent Clinical Hospital 2 PUM — Szczecin, West Pomeranian Voivodeship, Poland (enrolling)
Full record on ClinicalTrials.gov
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