Overview
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
Description
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.
Eligibility
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)