Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease

Multicenter study aimed at collecting post-market clinical data on the VESTO® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. The objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the Vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.

Inclusion criteria

• 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;
• Compliance with the device's instructions for use (IFU);
• Patient availability for appropriate follow-up times for the duration of the study;
• Patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form.

Exclusion criteria

• 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;
• Patient undergoing chemotherapy or radiation therapy;
• Patient with a stent or graft located in the target limb;
• Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study;
• Patient with a life expectancy of less than 12 months;
• Inability to undergo dual antiplatelet therapy (DAPT)