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

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT06573437
• Lead Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.

Brief 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

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.

Study Timeline

• Study Start: 2024-06-21
• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 18 years of age or older;
2. TASC-II aortoiliac lesion classification of modified class A, B, C, or D;
3. Rutherford classification score of 2 to 5;
4. Access site compatibility with the device delivery system;
5. Compliance with the device's instructions for use (IFU);
6. Patient availability for appropriate follow-up times for the duration of the study;
7. Patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form.

Exclusion Criteria

1. Known hypersensitivity to heparin, contrast media, or stent components;
2. Patient with blood dyscrasia;
3. Pregnant or breastfeeding women;
4. Patient currently participating in an investigational drug or device study;
5. Patient undergoing chemotherapy or radiation therapy;
6. Patient with a stent or graft located in the target limb;
7. Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study;
8. Patient with a life expectancy of less than 12 months;
9. Inability to undergo dual antiplatelet therapy (DAPT)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)	30 days post index procedure	Absence of rupture or dissection of the treated vessel within 30 days after the procedure
Incidence of Device-Related Serious Adverse Events (Device Safety)	30 days post-index procedure	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
Number of Patients with Technical Success (Device Performance)	Intraoperative	Technical success with the absence of serious adverse events related to the device

Secondary Outcome Measures

Name	Time	Method
Primary Patency Rate	30 days post index procedure	Defined as the absence of restenosis \> 50% within 30 days
Rate of Target Vessel Patency	3, 6, 9, and 12 months	Absence of restenosis \> 50%
Limb Salvage Rate	30 days, 6, 9, and 12 months	When patients with rest pain experienced pain relief and those with foot ulcers showed improved perfusion, avoiding the need for amputation
Number of Patients with Clinical Success	30 days, 3, 6, 9, and 12 months	Defined by symptom improvement
Incidence of Adverse Events	30 days, 3, 6, 9, and 12 months	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
Rate of Technical Success	Intraoperative	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)
Rate of Procedural Success	30 days post index procedure	Defined as the absence of serious adverse events related to the device within 30 days
Conversion Rate to Open Surgery	Intraoperative	Rate of patients who required conversion to open surgery
Need for Endovascular Reintervention at the Target Lesion	30 days, 3, 6, 9, and 12 months	Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention

Trial Locations

Locations (6)

Hospital Ana Nery; 🇧🇷 Salvador, BA, Brazil

Hospital Santa Helena; 🇧🇷 Goiânia, GO, Brazil

Hospital Universitário Pedro Ernesto (HUPE-UERJ); 🇧🇷 Rio de Janeiro, RJ, Brazil

HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista; 🇧🇷 Botucatu, SP, Brazil

Hospital de Clínicas da Universidade Estadual de Campinas; 🇧🇷 Campinas, SP, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; 🇧🇷 Ribeirão Preto, SP, Brazil