Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease

Официальное название

Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Vascular Stent - Vesto Endoprosthesis
  Vascular Stent Implant - Vesto Endoprosthesis

Первичные конечные точки

• Incidence of Device-Related Serious Adverse Events (Device Safety) [Срок оценки: 30 days post-index procedure]
• Number of Patients with Technical Success (Device Performance) [Срок оценки: Intraoperative]
• Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome) [Срок оценки: 30 days post index procedure]

Вторичные конечные точки (9)

• Rate of Technical Success [Срок оценки: Intraoperative]
• Rate of Procedural Success [Срок оценки: 30 days post index procedure]
• Incidence of Adverse Events [Срок оценки: 30 days, 3, 6, 9, and 12 months]
• Conversion Rate to Open Surgery [Срок оценки: Intraoperative]
• Primary Patency Rate [Срок оценки: 30 days post index procedure]
• Number of Patients with Clinical Success [Срок оценки: 30 days, 3, 6, 9, and 12 months]
• Rate of Target Vessel Patency [Срок оценки: 3, 6, 9, and 12 months]
• Limb Salvage Rate [Срок оценки: 30 days, 6, 9, and 12 months]
• Need for Endovascular Reintervention at the Target Lesion [Срок оценки: 30 days, 3, 6, 9, and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 6 центров

• 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

Идентификаторы

NCT: NCT06573437 · VESTO PMCF - Iliac Stent trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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