Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease (VESTO-ILIAC)

March 21, 2025 updated by: Braile Biomedica Ind. Com. e Repr. Ltda.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • BA
      • Salvador, BA, Brazil, 40301-155
        • Recruiting
        • Hospital Ana Nery
        • Principal Investigator:
          • André Brito
    • GO
      • Goiânia, GO, Brazil, 74083-100
        • Recruiting
        • Hospital Santa Helena
        • Principal Investigator:
          • Fabio Cypreste Oliveira
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20551-030
        • Recruiting
        • Hospital Universitário Pedro Ernesto (HUPE-UERJ)
        • Principal Investigator:
          • Cristina Rigetti
    • SP
      • Botucatu, SP, Brazil, 18618-970
        • Recruiting
        • HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
        • Principal Investigator:
          • Marcone Sobreira
      • Campinas, SP, Brazil, 13083-888
        • Not yet recruiting
        • Hospital de Clínicas Da Universidade Estadual de Campinas
        • Principal Investigator:
          • Ana Terezinha Guillaumon
      • Ribeirão Preto, SP, Brazil, 14015-010
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
        • Principal Investigator:
          • Edwaldo Joviliano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Device-Related Serious Adverse Events (Device Safety)
Time Frame: 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
30 days post-index procedure
Number of Patients with Technical Success (Device Performance)
Time Frame: Intraoperative
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)
Time Frame: 30 days post index procedure
Absence of rupture or dissection of the treated vessel within 30 days after the procedure
30 days post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Technical Success
Time Frame: 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)
Intraoperative
Rate of Procedural Success
Time Frame: 30 days post index procedure
Defined as the absence of serious adverse events related to the device within 30 days
30 days post index procedure
Incidence of Adverse Events
Time Frame: 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
30 days, 3, 6, 9, and 12 months
Conversion Rate to Open Surgery
Time Frame: Intraoperative
Rate of patients who required conversion to open surgery
Intraoperative
Primary Patency Rate
Time Frame: 30 days post index procedure
Defined as the absence of restenosis > 50% within 30 days
30 days post index procedure
Number of Patients with Clinical Success
Time Frame: 30 days, 3, 6, 9, and 12 months
Defined by symptom improvement
30 days, 3, 6, 9, and 12 months
Rate of Target Vessel Patency
Time Frame: 3, 6, 9, and 12 months
Absence of restenosis > 50%
3, 6, 9, and 12 months
Limb Salvage Rate
Time Frame: 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
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
Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention
30 days, 3, 6, 9, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Braile Biomedica Ind. Com. e Repr. Ltda.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fabio Cypreste Oliveira, Hospital Santa Helena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VESTO PMCF - Iliac Stent trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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