Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Type IA Endoleak
Conditions
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
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
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
PROCEDUREPhysician-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.
Sponsors
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 to angio - 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 of thrombi, 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 \<1cm of 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 and hepatic aortic artery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Surviving at 1 Year Without Aortic Rupture | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths from Any Cause Within 1 Year | 1 year | Total number of participant deaths due to any cause occurring within one year of the procedure. |
| Number of Cardiovascular-Related Deaths Within 1 Year | 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. |
| Number of Participants Without Aneurysm Growth at 1 Year | 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. |
| Number of Participants Surviving Without Reintervention at 1 Year | 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. |
| Change in Incidence of Cardiovascular Events at 1 Year | 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. |
| Number of Deaths from Any Cause at 1 Year (Overall Mortality) | 1 year | The total number of participant deaths from any cause within one year of the stent-graft procedure. |
| Change in Renal Function at 1 Year | 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. |
| Total Cost of Treatment at 1 Year | 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. |
Countries
Poland
Contacts
CONTACTPawel Rynio
Outcome results
None listed