This study will validate the efficacy and safety of the VESTO® Vascular Stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial
18 years of age or older;
TASC-II aortoiliac lesion classification of modified class A, B, C, or D;
Rutherford classification score of 2 to 5;
Access site compatibility with the device delivery system;
Known hypersensitivity to heparin, contrast media, or stent components;
Patient with blood dyscrasia;
Pregnant or breastfeeding women;
Patient currently participating in an investigational drug or device study;
Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.
Cohort
Prospective
Vascular Stent - Vesto Endoprosthesis
DeviceVascular Stent Implant - Vesto Endoprosthesis
Incidence of Device-Related Serious Adverse Events (Device Safety)
Absence of major serious adverse events occurring within 30 days after the index procedure, defined as device- or procedure-related death, acute myocardial infarction (AMI), or above-the-metatarsal amputation in the treated leg due to a vascular event
Number of Patients with Technical Success (Device Performance)
Technical success with the absence of serious adverse events related to the device
Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)
Absence of rupture or dissection of the treated vessel within 30 days after the procedure
Rate of Technical Success
Defined as the successful deployment of the endoprosthesis at the intended site with patency and absence of significant device deformities (e.g., kinks, stent eversion, twisting)
Rate of Procedural Success
Defined as the absence of serious adverse events related to the device within 30 days
Incidence of Adverse Events
Defined as device- or procedure-related death, bleeding or hematoma, myocardial infarction (MI), thrombosis, arterial rupture or dissection, or amputation above the metatarsal in the treated leg due to a vascular event
Conversion Rate to Open Surgery
Rate of patients who required conversion to open surgery
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