Actively Recruiting
Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
Led by Braile Biomedica Ind. Com. e Repr. Ltda. · Updated on 2025-03-26
100
Participants Needed
6
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Availability for appropriate follow-up times during the study
- Informed consent signed after being informed about the study
You will not qualify if you...
- Known hypersensitivity to heparin, contrast media, or stent components
- Blood dyscrasia
- Pregnant or breastfeeding women
- Currently participating in another investigational drug or device study
- Undergoing chemotherapy or radiation therapy
- Having a stent or graft in the target limb
- Angioplasty or bypass surgery within 30 days prior to study
- Life expectancy less than 12 months
- Unable to undergo dual antiplatelet therapy (DAPT)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil, 40301-155
Actively Recruiting
2
Hospital Santa Helena
Goiânia, Goiás, Brazil, 74083-100
Actively Recruiting
3
Hospital Universitário Pedro Ernesto (HUPE-UERJ)
Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
Actively Recruiting
4
HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Botucatu, São Paulo, Brazil, 18618-970
Actively Recruiting
5
Hospital de Clínicas da Universidade Estadual de Campinas
Campinas, São Paulo, Brazil, 13083-888
Not Yet Recruiting
6
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14015-010
Actively Recruiting
Research Team
G
Glaucia Basso
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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