the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Implantation of a physician-modified fenestrated stent-graft using a patient-specific 3D-printed aortic template, performed via an endovascular approach.
An Independent Clinical Hospital 2 PUM
Szczecin, West Pomeranian Voivodeship, Poland
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year