Peripheral Arterial DiseaseVESTO-ILIACNCT06573437
Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
An observational study of Peripheral Arterial Disease, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 6 sites in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Vascular Stent - Vesto Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 6 sitesBrazil
- Study dates
- 21 Jun 2024to Aug 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
Botucatu, São Paulo, 18618-970
Hospital de Clínicas da Universidade Estadual de Campinas
Campinas, São Paulo, 13083-888
Hospital Santa Helena
Goiânia, Goiás, 74083-100
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14015-010
Hospital Universitário Pedro Ernesto (HUPE-UERJ)
Rio de Janeiro, Rio de Janeiro, 20551-030
Hospital Ana Nery
Salvador, Estado de Bahia, 40301-155
About this study
Official title: 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
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Vascular Stent - Vesto Endoprosthesis
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Stent - Vesto EndoprosthesisDevice
Vascular Stent Implant - Vesto Endoprosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 30 days post index procedure
Secondary outcomes (9)
Rate of Technical Success
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)
Measured: Intraoperative
Rate of Procedural Success
Defined as the absence of serious adverse events related to the device within 30 days
Measured: 30 days post index procedure
Incidence of Adverse Events
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
Measured: 30 days, 3, 6, 9, and 12 months
Conversion Rate to Open Surgery
Rate of patients who required conversion to open surgery
Measured: Intraoperative
Primary Patency Rate
Defined as the absence of restenosis > 50% within 30 days
Measured: 30 days post index procedure
Number of Patients with Clinical Success
Defined by symptom improvement
Measured: 30 days, 3, 6, 9, and 12 months
Rate of Target Vessel Patency
Absence of restenosis > 50%
Measured: 3, 6, 9, and 12 months
Limb Salvage Rate
When patients with rest pain experienced pain relief and those with foot ulcers showed improved perfusion, avoiding the need for amputation
Measured: 30 days, 6, 9, and 12 months
Need for Endovascular Reintervention at the Target Lesion
Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention
Measured: 30 days, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start21 Jun 2024
- Primary completion1 Aug 2025
- Study completionAug 2027 (estimated)
Why it stopped: Low recruitment potential, limiting the feasibility of achieving the planned sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabio Cypreste Oliveira, Principal investigator, Hospital Santa Helena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573437
- Sponsor's protocol ID
- VESTO PMCF - Iliac Stent trial
- Acronym
- VESTO-ILIAC
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial
- ClinicalTrials.gov ID
- NCT06573437
- Acronym / sponsor ID
- VESTO-ILIAC / VESTO PMCF - Iliac Stent trial
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Low recruitment potential, limiting the feasibility of achieving the planned sample size.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular Stent - Vesto EndoprosthesisVascular Stent Implant - Vesto Endoprosthesis | Device | – |
Primary outcome
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
Number of Patients with Technical Success (Device Performance)
Time frame: Intraoperative
Technical success with the absence of serious adverse events related to the device
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
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Cypreste Oliveira principal investigator
Hospital Santa Helena
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device-Related Serious Adverse Events (Device Safety) (time frame: 30 days post-index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.