RecruitingNot Applicable

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

Poland100 participantsStarted 2022-11-01

Plain-language summary

the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Number of Participants Surviving at 1 Year Without Aortic Rupture

Timeframe: 1 year

Number of Participants Surviving at 30 Days Post-Procedure (Perioperative Survival)

Timeframe: 30 days

Trial details

NCT IDNCT06969729

SponsorSamodzielny Publiczny Szpital Kliniczny nr 2 PUM

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Pawel Rynio

914661156 p.rynio@spsk2.szczecin.pl

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials