Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Poland
An Independent Clinical Hospital 2 PUM
RECRUITING
Szczecin
Contact Information
Primary
Pawel Rynio
p.rynio@spsk2.szczecin.pl
914661156
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 100
Treatments
Experimental: Physician-Modified Stent-Grafts Made Using 3D Aortic Template
Patients with aortic pathology undergoing implantation of physician-modified stent-grafts created using a patient-specific 3D-printed aortic template.
Active_comparator: Custom-Made Fenestrated Stent-Graft
Implantation of a commercially manufactured, patient-specific custom-made fenestrated stent-graft via an endovascular approach.
Sponsors
Leads: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

This content was sourced from clinicaltrials.gov