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

Last updated: May 12, 2025
Sponsor: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Overall Status: Active - Recruiting

Phase

2/3

Condition

Aneurysm

Cardiovascular Disease

Heart Disease

Treatment

Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)

Clinical Study ID

NCT06969729
2020/ABM/01/00121/P/02
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 IVthoracoabdominal aneurysm of diameter >5.5cm (male) and 5.2cm (female)

  • Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IVthoraco-abdominal aneurysm with aneurysm growth rate ≥ 0.5cm during 6 months

  • Type IA endoleak of post-implantation of abdominal stent- graft 3. Iliac arteriesmorphology with aortic stent graft implantation to be restored 4. Aortic segmentwhich is proximal to aneurysm

  • Length ≥20mm

  • Diameter 20mm-36mm

  • Aortic suprarenal angle ≤75 degrees 5. Survival > 2 years

Exclusion

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 toangio - 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 ofthrombi, 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 <1cmof 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 andhepatic aortic artery

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)
Phase: 2/3
Study Start date:
November 01, 2022
Estimated Completion Date:
April 30, 2027

Study 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 aneurysm, thoracic-abdominal aneurysm type IV or type IA endoleak.

Approximately 100 eligible patients will be randomized in a 1:1 ratio into 2 arms (n=50 in each arm) Arm A treated with innovative angiosurgery intervention Arm B standard procedure Study will use an Interactive Web Response System (IWRS) for randomization. Randomization will be used to minimize bias in the assignment of subjects to treatment groups, to increase the likelihood that known and unknown subject attributes (e.g. demographic and baseline characteristics) are evenly balanced, and to enhance the validity of statistical comparisons across treatment groups.

Subjects will be randomized based on following stratification: • Site

• Aneurysm class Subject participation will include a Screening Phase, Intervention Phase, Safety follow-up and End of Study.

The screening phase will last up to 28 days before the therapeutic intervention periods starts (two hospitalizations finished with 2 angio surgery intervention) during which the subject's eligibility and baseline characteristics will be determined. The therapeutic intervention will last from randomization until second hospitalization will end with angio surgery intervention). There will be 2 follow up visits. Safety follow up will lasts 12 months.

Aorta assessment by angio CT will be performed at screening, intervention period at hospitalization no. 1 and in 30 day follow up, 12 month follow up

Connect with a study center

  • An Independent Clinical Hospital 2 PUM

    Szczecin, Zachodniopomorskie 70-111
    Poland

    Active - Recruiting

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