Recruiting
Not applicable
Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
Condition(s) studied
Abdominal Aortic AneurysmJuxtarenal Abdominal Aortic AneurysmPararenal Abdominal Aortic AneurysmThoracoabdominal Aortic AneurysmType IA Endoleak
Investigational drug(s) / intervention(s)
Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)
Physician-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.
Study 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
Inclusion Criteria:
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 Criteria:
1. Female and male subjects age \<18
2. Pregnancy and breast feeding
3. Allergy and hypersensitivity to matherials of which the stent- graft is composed
4. Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated medically
5. Coagulopathy which cannot medically treated
6. Active infection which might cause stent - graft infection
7. Creatinine level \> 3.0mg/dL
8. Marphan syndrome, Ehlers - Denlos syndrome
9. Unstable angina pectoris
10. Raptured aortic aneurysm caused by cardiac insufficiency
11. Unwillingness to comply with protocol procedures
12. Iliac arteries morphology adequate for stent-graft implantation
13. The diameter of the aortic flow lumen in reno-visceral aorta greater than 34mm
14. Aortic section which is proximal to celiac artery with significant number of thrombi, calcification or changed by aneurysm
15. Aorta with significant number of irregular thrombi which may lead to embolism ("shaggy aorta")
16. Diameter of proximal kidney arteries which is exercisable to stenting \<4.5mm
17. 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
18. Atypical anatomy of celiac artery in the form of separate exit of splenic and hepatic aortic artery
Primary outcome measure(s)
- Number of Participants Surviving at 1 Year Without Aortic Rupture — 1 year
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) — 30 days
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.
Trial sites (1)
| Facility | City | Region | Status |
| An Independent Clinical Hospital 2 PUM |
Szczecin |
West Pomeranian Voivodeship |
Recruiting |
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