Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vascular Stent - Vesto Endoprosthesis.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial
Overview
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
Detailed description
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.
Interventions
- Device Vascular Stent - Vesto Endoprosthesis
Vascular Stent Implant - Vesto Endoprosthesis
Primary outcome measures
- Incidence of Device-Related Serious Adverse Events (Device Safety) [Time frame: 30 days post-index procedure]
- Number of Patients with Technical Success (Device Performance) [Time frame: Intraoperative]
- Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome) [Time frame: 30 days post index procedure]
Secondary outcome measures (9)
- Rate of Technical Success [Time frame: Intraoperative]
- Rate of Procedural Success [Time frame: 30 days post index procedure]
- Incidence of Adverse Events [Time frame: 30 days, 3, 6, 9, and 12 months]
- Conversion Rate to Open Surgery [Time frame: Intraoperative]
- Primary Patency Rate [Time frame: 30 days post index procedure]
- Number of Patients with Clinical Success [Time frame: 30 days, 3, 6, 9, and 12 months]
- Rate of Target Vessel Patency [Time frame: 3, 6, 9, and 12 months]
- Limb Salvage Rate [Time frame: 30 days, 6, 9, and 12 months]
- Need for Endovascular Reintervention at the Target Lesion [Time frame: 30 days, 3, 6, 9, and 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Known hypersensitivity to heparin, contrast media, or stent components;
- Patient with blood dyscrasia;
- Pregnant or breastfeeding women;
- Patient currently participating in an investigational drug or device study;
- Patient undergoing chemotherapy or radiation therapy;
- Patient with a stent or graft located in the target limb;
- Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study;
- Patient with a life expectancy of less than 12 months;
- Inability to undergo dual antiplatelet therapy (DAPT)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 6 centers
- Hospital Ana Nery — Salvador
- Hospital Santa Helena — Goiânia
- Hospital Universitário Pedro Ernesto (HUPE-UERJ) — Rio de Janeiro
- HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade E — Botucatu
- Hospital de Clínicas da Universidade Estadual de Campinas — Campinas
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto — Ribeirão Preto
Identifiers
NCT: NCT06573437 · VESTO PMCF - Iliac Stent trial