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Tests treatment safety and results for Abdominal Aortic Aneurysm
Official title Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
ClinicalTrials.gov ID: NCT06969729
What this study is testing
- What it's testing
- the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Female and male people age ≥ 18 2. Subject need to meet one of the following criteria:
- people with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoracoabdominal aneurysm of diameter \>5.5cm (male) and 5.2cm (female)
- people 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...
- Length ≥20mm
You likely can't join if
- Female and male people 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
See the full eligibility criteria
- Female and male people age ≥ 18 2. Subject need to meet one of the following criteria:
- people with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoracoabdominal aneurysm of diameter \>5.5cm (male) and 5.2cm (female)
- people 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
- Female and male people 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
The study team makes the final eligibility decision.
Where it's taking place
- Szczecin, West Pomeranian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Szczecin, West Pomeranian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.