Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
NCT Number: NCT06573437
Acronym: VESTO-ILIAC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Peripheral Arterial Disease
Interventions: DEVICE: Vascular Stent - Vesto Endoprosthesis
Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2026-08
Locations: Hospital Ana Nery, Salvador, BA, 40301-155, Brazil|Hospital Santa Helena, Goiânia, GO, 74083-100, Brazil|Hospital Universitário Pedro Ernesto (HUPE-UERJ), Rio de Janeiro, RJ, 20551-030, Brazil|HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista, Botucatu, SP, 18618-970, Brazil|Hospital de Clínicas da Universidade Estadual de Campinas, Campinas, SP, 13083-888, Brazil|Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, 14015-010, Brazil

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

Primary Outcome Measures: Incidence of Device-Related Serious Adverse Events (Device Safety), Absence of major serious adverse events occurring within 30 days after the index procedure, defined as device- or procedure-related death, acute myocardial infarction (AMI), or above-the-metatarsal amputation in the treated leg due to a vascular event, 30 days post-index procedure|Number of Patients with Technical Success (Device Performance), Technical success with the absence of serious adverse events related to the device, Intraoperative|Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome), Absence of rupture or dissection of the treated vessel within 30 days after the procedure, 30 days post index procedure
Secondary Outcome Measures: Rate of Technical Success, Defined as the successful deployment of the endoprosthesis at the intended site with patency and absence of significant device deformities (e.g., kinks, stent eversion, twisting), Intraoperative|Rate of Procedural Success, Defined as the absence of serious adverse events related to the device within 30 days, 30 days post index procedure|Incidence of Adverse Events, Defined as device- or procedure-related death, bleeding or hematoma, myocardial infarction (MI), thrombosis, arterial rupture or dissection, or amputation above the metatarsal in the treated leg due to a vascular event, 30 days, 3, 6, 9, and 12 months|Conversion Rate to Open Surgery, Rate of patients who required conversion to open surgery, Intraoperative|Primary Patency Rate, Defined as the absence of restenosis \> 50% within 30 days, 30 days post index procedure|Number of Patients with Clinical Success, Defined by symptom improvement, 30 days, 3, 6, 9, and 12 months|Rate of Target Vessel Patency, Absence of restenosis \> 50%, 3, 6, 9, and 12 months|Limb Salvage Rate, When patients with rest pain experienced pain relief and those with foot ulcers showed improved perfusion, avoiding the need for amputation, 30 days, 6, 9, and 12 months|Need for Endovascular Reintervention at the Target Lesion, Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention, 30 days, 3, 6, 9, and 12 months