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ID06573437

Evaluating the Safety and Effectiveness of the VESTO Vascular Stent in Patients with Iliac Peripheral Arterial Disease Post-Market Clinical Study

Led by Braile Biomedica Ind. Com. e Repr. Ltda. · Updated on 2025-03-26

100

Participants Needed

6

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the VESTO4 vascular stent in a post-market clinical trial to treat patients with iliac peripheral arterial occlusive disease. This multicenter study aims to collect clinical data on the stents safety and effectiveness, focusing on short-term outcomes within 12 months after the procedure. Participants will receive the VESTO4 vascular stent through an endovascular intervention designed to open blocked arteries in the iliac region. The study tracks the stents performance during the procedure and monitors safety outcomes such as device-related adverse events and vessel integrity up to 30 days post-procedure. Follow-up assessments will continue for up to one year. During the study, participants will undergo evaluations including technical and procedural success rates, adverse event monitoring at multiple time points, limb salvage rates, and need for repeat interventions. Researchers will collect these data at intervals including 30 days, 3, 6, 9, and 12 months to assess the stents clinical performance and safety over time.

CONDITIONS

Brief Title

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

Research Team

G

Glaucia Basso

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