Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
RECRUITING
Botucatu
Hospital de Clínicas da Universidade Estadual de Campinas
NOT_YET_RECRUITING
Campinas
Hospital Santa Helena
RECRUITING
Goiânia
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
RECRUITING
Ribeirão Preto
Hospital Universitário Pedro Ernesto (HUPE-UERJ)
RECRUITING
Rio De Janeiro
Hospital Ana Nery
RECRUITING
Salvador
Contact Information
Primary
Glaucia Basso
glaucia.basso@braile.com.br
+55 (17) 2136-7005
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Braile Biomedica Ind. Com. e Repr. Ltda.