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

NCT06573437 | Recruiting DMC

• 1 other identifier: VESTO PMCF - Iliac Stent trial
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Rate of Technical Success

  Intraoperative

• Rate of Procedural Success

  30 days post index procedure

• Incidence of Adverse Events

  30 days, 3, 6, 9, and 12 months

• Conversion Rate to Open Surgery

  Intraoperative

• Primary Patency Rate

  30 days post index procedure

Interventions

Vascular Stent - Vesto Endoprosthesis DEVICE

Vascular Stent Implant - Vesto Endoprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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 with a life expectancy of less than 12 months;
• Inability to undergo dual antiplatelet therapy (DAPT)

Sponsors & Collaborators

• Braile Biomedica Ind. Com. e Repr. Ltda.: lead

Study Sites (6)

Hospital Ana Nery

Salvador, Estado de Bahia, 40301-155, Brazil

RECRUITING

Hospital Santa Helena

Goiânia, Goiás, 74083-100, Brazil

RECRUITING

Hospital Universitário Pedro Ernesto (HUPE-UERJ)

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

RECRUITING

HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista

Botucatu, São Paulo, 18618-970, Brazil

RECRUITING

Hospital de Clínicas da Universidade Estadual de Campinas

Campinas, São Paulo, 13083-888, Brazil

NOT YET RECRUITING

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14015-010, Brazil

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Fabio Cypreste Oliveira

  Hospital Santa Helena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glaucia Basso

CONTACT

+55 (17) 2136-7005; glaucia.basso@braile.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 27, 2024
• Study Start: June 21, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)