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

Last updated: March 21, 2025
Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Claudication

Peripheral Arterial Occlusive Disease

Treatment

Vascular Stent - Vesto Endoprosthesis

Clinical Study ID

NCT06573437
VESTO PMCF - Iliac Stent trial
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older;

  2. TASC-II aortoiliac lesion classification of modified class A, B, C, or D;

  3. Rutherford classification score of 2 to 5;

  4. Access site compatibility with the device delivery system;

  5. Compliance with the device's instructions for use (IFU);

  6. Patient availability for appropriate follow-up times for the duration of the study;

  7. Patient informed about the nature of the study, agreeing to its provisions, andsigning the informed consent form.

Exclusion

Exclusion Criteria:

  1. Known hypersensitivity to heparin, contrast media, or stent components;

  2. Patient with blood dyscrasia;

  3. Pregnant or breastfeeding women;

  4. Patient currently participating in an investigational drug or device study;

  5. Patient undergoing chemotherapy or radiation therapy;

  6. Patient with a stent or graft located in the target limb;

  7. Patient who underwent angioplasty or bypass surgery within 30 days prior toinclusion in this study;

  8. Patient with a life expectancy of less than 12 months;

  9. Inability to undergo dual antiplatelet therapy (DAPT)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Vascular Stent - Vesto Endoprosthesis
Phase:
Study Start date:
June 21, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Hospital Ana Nery

    Salvador, BA 40301-155
    Brazil

    Active - Recruiting

  • Hospital Santa Helena

    Goiânia, GO 74083-100
    Brazil

    Active - Recruiting

  • Hospital Universitário Pedro Ernesto (HUPE-UERJ)

    Rio de Janeiro, RJ 20551-030
    Brazil

    Active - Recruiting

  • HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista

    Botucatu, SP 18618-970
    Brazil

    Active - Recruiting

  • Hospital de Clínicas da Universidade Estadual de Campinas

    Campinas, SP 13083-888
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto, SP 14015-010
    Brazil

    Active - Recruiting

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