Status:
RECRUITING
Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Lead Sponsor:
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Conditions:
Abdominal Aortic Aneurysm
Juxtarenal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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
Detailed Description
This is randomized, multicenter, open-label, 2 -arm Study to evaluate the efficacy and safety in stent-graft application of arm A and Arm B in patients with juxtarenal or pararenal abdominal aortic an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06969729
Start Date
November 1 2022
End Date
April 30 2027
Last Update
May 14 2025
Active Locations (1)
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1
An Independent Clinical Hospital 2 PUM
Szczecin, West Pomeranian Voivodeship, Poland, 70-111