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

Official title

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

Overview

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

Detailed 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

Interventions

• Procedure Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)
  Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.

Primary outcome measures

• Number of Participants Surviving at 1 Year Without Aortic Rupture [Time frame: 1 year]
• Number of Participants Surviving at 30 Days Post-Procedure (Perioperative Survival) [Time frame: 30 days]

Secondary outcome measures (8)

• Number of Deaths from Any Cause Within 1 Year [Time frame: 1 year]
• Number of Cardiovascular-Related Deaths Within 1 Year [Time frame: 1 year]
• Number of Participants Without Aneurysm Growth at 1 Year [Time frame: 1 year]
• Number of Participants Surviving Without Reintervention at 1 Year [Time frame: 1 year]
• Change in Incidence of Cardiovascular Events at 1 Year [Time frame: 1 year]
• Number of Deaths from Any Cause at 1 Year (Overall Mortality) [Time frame: 1 year]
• Change in Renal Function at 1 Year [Time frame: 1 year]
• Total Cost of Treatment at 1 Year [Time frame: 1 year]

Eligibility criteria

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 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

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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Poland · 1 center

• An Independent Clinical Hospital 2 PUM — Szczecin

Publications

• 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

Identifiers

NCT: NCT06969729 · 2020/ABM/01/00121/P/02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗