Evaluating the VESTO® Vascular Stent for Iliac Arterial Disease

Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial

This study is testing the VESTO® vascular stent to see if it safely helps people with iliac artery disease feel better over the next year.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Salvador, Estado de Bahia and 5 other locations)
• Trial ID: NCT06573437 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the safety and efficacy of the VESTO® vascular stent in treating iliac peripheral arterial obstructive disease. It is a multicenter trial that will collect post-market clinical data to assess the short-term performance of the stent over a 12-month period. Eligible patients will undergo endovascular intervention with the VESTO® stent, and their outcomes will be monitored to ensure compliance with safety standards and clinical effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific classifications of arterial lesions and Rutherford scores indicating moderate to severe symptoms.

Not a fit: Patients with known hypersensitivity to stent components or those currently undergoing chemotherapy or radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from iliac peripheral arterial disease.

How similar studies have performed: Other studies have shown success with similar vascular stent interventions, indicating a promising approach for treating peripheral arterial disease.

Eligibility criteria

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, and signing the informed consent form.

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 to inclusion in this study;
8. Patient with a life expectancy of less than 12 months;
9. Inability to undergo dual antiplatelet therapy (DAPT)

Where this trial is running

Salvador, Estado de Bahia and 5 other locations

• Hospital Ana Nery — Salvador, Estado de Bahia, Brazil (Recruiting)
• Hospital Santa Helena — Goiânia, Goiás, Brazil (Recruiting)
• Hospital Universitário Pedro Ernesto (HUPE-UERJ) — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
• HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista — Botucatu, São Paulo, Brazil (Recruiting)
• Hospital de Clínicas da Universidade Estadual de Campinas — Campinas, São Paulo, Brazil (Not_yet_recruiting)
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto — Ribeirão Preto, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Fabio Cypreste Oliveira — Hospital Santa Helena
• Study coordinator: Glaucia Basso

Conditions Peripheral Arterial Disease