Status:
RECRUITING
Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
Lead Sponsor:
Braile Biomedica Ind. Com. e Repr. Ltda.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief Summary
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
Detailed 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 inter...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06573437
Start Date
June 21 2024
End Date
August 1 2026
Last Update
March 26 2025
Active Locations (6)
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1
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil, 40301-155
2
Hospital Santa Helena
Goiânia, Goiás, Brazil, 74083-100
3
Hospital Universitário Pedro Ernesto (HUPE-UERJ)
Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
4
HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Botucatu, São Paulo, Brazil, 18618-970