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

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT06573437
• Lead Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> 1. 18 years of age or older;<br><br> 2. TASC-II aortoiliac lesion classification of modified class A, B, C, or D;<br><br> 3. Rutherford classification score of 2 to 5;<br><br> 4. Access site compatibility with the device delivery system;<br><br> 5. Compliance with the device's instructions for use (IFU);<br><br> 6. Patient availability for appropriate follow-up times for the duration of the study;<br><br> 7. Patient informed about the nature of the study, agreeing to its provisions, and<br> signing the informed consent form.<br><br>Exclusion Criteria:<br><br> 1. Known hypersensitivity to heparin, contrast media, or stent components;<br><br> 2. Patient with blood dyscrasia;<br><br> 3. Pregnant or breastfeeding women;<br><br> 4. Patient currently participating in an investigational drug or device study;<br><br> 5. Patient undergoing chemotherapy or radiation therapy;<br><br> 6. Patient with a stent or graft located in the target limb;<br><br> 7. Patient who underwent angioplasty or bypass surgery within 30 days prior to<br> inclusion in this study;<br><br> 8. Patient with a life expectancy of less than 12 months;<br><br> 9. Inability to undergo dual antiplatelet therapy (DAPT)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Device-Related Serious Adverse Events (Device Safety);Number of Patients with Technical Success (Device Performance);Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)

Secondary Outcome Measures

Name	Time	Method
Rate of Technical Success;Rate of Procedural Success;Incidence of Adverse Events;Conversion Rate to Open Surgery;Primary Patency Rate;Number of Patients with Clinical Success;Rate of Target Vessel Patency;Limb Salvage Rate;Need for Endovascular Reintervention at the Target Lesion