Abdominal Aortic AneurysmNCT06969729
Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology
A study testing Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided) in people with Abdominal Aortic Aneurysm and Juxtarenal Abdominal Aortic Aneurysm, run by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM at 1 site in Poland.
Trial summary
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm
- What is being tested?
- Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
An Independent Clinical Hospital 2 PUM
Szczecin, West Pomeranian Voivodeship, 70-111
Pawel Rynio, MD PHD, +914661156, p.rynio@spsk2-szczecin.pl
About this study
Official title: Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial
the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
Read the 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
- Conditions
- Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Type IA Endoleak
- Being tested
- Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)
- 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
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)Procedure or surgery
Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (8)
Number of Deaths from Any Cause Within 1 Year
Total number of participant deaths due to any cause occurring within one year of the procedure.
Measured: 1 year
Number of Cardiovascular-Related Deaths Within 1 Year
The number of participant deaths attributed to cardiovascular causes (e.g., myocardial infarction, stroke, aortic rupture) within 1 year of the procedure, as adjudicated by the study investigators.
Measured: 1 year
Number of Participants Without Aneurysm Growth at 1 Year
The number of participants whose aneurysm size remains stable (no increase >5 mm in maximum diameter) as assessed by imaging (e.g., CT angiography) at 1 year post-implantation.
Measured: 1 year
Number of Participants Surviving Without Reintervention at 1 Year
The number of participants who do not require any secondary endovascular or surgical intervention related to the index aortic pathology within 1 year of the initial procedure.
Measured: 1 year
Change in Incidence of Cardiovascular Events at 1 Year
Change in the number of participants experiencing cardiovascular events (e.g., myocardial infarction, stroke, cardiac arrest) compared to baseline rates or historical controls over a 1-year follow-up period.
Measured: 1 year
Number of Deaths from Any Cause at 1 Year (Overall Mortality)
The total number of participant deaths from any cause within one year of the stent-graft procedure.
Measured: 1 year
Change in Renal Function at 1 Year
Change in estimated glomerular filtration rate (eGFR) or serum creatinine level from baseline to 1 year post-procedure, used to assess renal function.
Measured: 1 year
Total Cost of Treatment at 1 Year
Cumulative healthcare cost per participant associated with the initial stent-graft procedure, hospitalization, follow-up visits, imaging, medications, and any reinterventions within 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Nov 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969729
- Sponsor's protocol ID
- 2020/ABM/01/00121/P/02
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional data governance policies and applicable data protection regulations, including the General Data Protection Regulation (GDPR) and national laws. These frameworks restrict the sharing of detailed clinical data with external parties to ensure the confidentiality and security of participant information.
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.
PubMed 35456273
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06969729
- Acronym / sponsor ID
- 2020/ABM/01/00121/P/02
- Conditions
- Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Type IA Endoleak
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samodzielny Publiczny Szpital Kliniczny nr 2 PUMUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physician-Modified Stent-Grafts Made Using 3D Aortic Template | Experimental | Procedure: Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)Patients with aortic pathology undergoing implantation of physician-modified stent-grafts created using a patient-specific 3D-printed aortic template. |
| Custom-Made Fenestrated Stent-Graft | Active comparator | Procedure: Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided)Implantation of a commercially manufactured, patient-specific custom-made fenestrated stent-graft via an endovascular approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Custom-Made Fenestrated Stent-Graft, Physician-Modified Stent-Grafts Made Using 3D Aortic Template |
Primary outcome
Number of Participants Surviving at 1 Year Without Aortic Rupture
Time frame: 1 year
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.
Number of Participants Surviving at 30 Days Post-Procedure (Perioperative Survival)
Time frame: 30 days
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 35456273Rynio 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional data governance policies and applicable data protection regulations, including the General Data Protection Regulation (GDPR) and national laws. These frameworks restrict the sharing of detailed clinical data with external parties to ensure the confidentiality and security of participant information.
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-Modified Fenestrated Stent-Graft (3D-Printed Template-Guided) in people with Abdominal Aortic Aneurysm and Juxtarenal Abdominal Aortic Aneurysm, run by Samodzielny Publiczny Szpital Kliniczny nr 2 PUM at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pawel Rynio (914661156, p.rynio@spsk2.szczecin.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Surviving at 1 Year Without Aortic Rupture (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06969729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.