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

NCT06969729 | Recruiting DMC

• 1 other identifier: 2020/ABM/01/00121/P/02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Juxtarenal Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm; Type IA Endoleak; Abdominal Aortic Aneurysm; Pararenal Abdominal Aortic Aneurysm

Keywords

AAA; physician-modified stent-graft; custom-made device; complex abdominal aortic aneurysm; juxtarenal abdominal aortic aneurysm; pararenal abdominal aortic aneurysm; thoracoabdominal aortic aneurysm; endovascular aneurysm repair; 3D printing; 3D model; PMEG; type IA endoleak; aortic stent-graft; PMSG; patient-specific 3D model; complex aortic pathology

Outcome Measures

Primary Outcomes (2)

• Number of Participants Surviving at 1 Year Without Aortic Rupture

  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.

  1 year

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

  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.

  30 days

Secondary Outcomes (8)

• Number of Deaths from Any Cause Within 1 Year

  1 year

• Number of Cardiovascular-Related Deaths Within 1 Year

  1 year

• Number of Participants Without Aneurysm Growth at 1 Year

  1 year

• Number of Participants Surviving Without Reintervention at 1 Year

  1 year

• Change in Incidence of Cardiovascular Events at 1 Year

  1 year

Study Arms (2)

Physician-Modified Stent-Grafts Made Using 3D Aortic Template

EXPERIMENTAL

Patients with aortic pathology undergoing implantation of physician-modified stent-grafts created using a patient-specific 3D-printed aortic template.

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

Custom-Made Fenestrated Stent-Graft

ACTIVE COMPARATOR

Implantation of a commercially manufactured, patient-specific custom-made fenestrated stent-graft via an endovascular approach.

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

Interventions

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

Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.

Custom-Made Fenestrated Stent-Graft; Physician-Modified Stent-Grafts Made Using 3D Aortic Template

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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")

Sponsors & Collaborators

• Samodzielny Publiczny Szpital Kliniczny nr 2 PUM: lead

Study Sites (1)

An Independent Clinical Hospital 2 PUM

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

RECRUITING

Related Publications (1)

• Rynio P, Jedrzejczak T, Rybicka A, Milner R, Gutowski P, Kazimierczak A. Initial Experience with Fenestrated Physician-Modified Stent Grafts Using 3D Aortic Templates. J Clin Med. 2022 Apr 13;11(8):2180. doi: 10.3390/jcm11082180. PMID: 35456273; PMCID: PMC9027705.

  RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Pawel Rynio

CONTACT

914661156; p.rynio@spsk2.szczecin.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel treatment arms. Arm A will receive treatment with physician-modified stent-grafts created using 3D models, and Arm B will receive treatment with custom-made devices. Outcomes will be compared between the two groups during follow-up.

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: May 14, 2025
• Study Start: November 1, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)