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
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.
Study Type
OBSERVATIONAL
Enrollment
100
Vascular Stent Implant - Vesto Endoprosthesis
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
RECRUITINGHospital Santa Helena
Goiânia, Goiás, Brazil
RECRUITINGHospital Universitário Pedro Ernesto (HUPE-UERJ)
Rio de Janeiro, Rio de Janeiro, Brazil
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
Time frame: 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
Time frame: 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
Time frame: 30 days post index procedure
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)
Time frame: Intraoperative
Rate of Procedural Success
Defined as the absence of serious adverse events related to the device within 30 days
Time frame: 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
Time frame: 30 days, 3, 6, 9, and 12 months
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HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Botucatu, São Paulo, Brazil
RECRUITINGHospital de Clínicas da Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
NOT_YET_RECRUITINGHospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
RECRUITINGConversion Rate to Open Surgery
Rate of patients who required conversion to open surgery
Time frame: Intraoperative
Primary Patency Rate
Defined as the absence of restenosis \> 50% within 30 days
Time frame: 30 days post index procedure
Number of Patients with Clinical Success
Defined by symptom improvement
Time frame: 30 days, 3, 6, 9, and 12 months
Rate of Target Vessel Patency
Absence of restenosis \> 50%
Time frame: 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
Time frame: 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
Time frame: 30 days, 3, 6, 9, and 12 months