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

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: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Vascular Stent - Vesto Endoprosthesis

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Glaucia Basso; Phone Number: +55 (17) 2136-7005; Email: glaucia.basso@braile.com.br

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Intraoperative
Rate of Procedural Success	Defined as the absence of serious adverse events related to the device within 30 days	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	30 days, 3, 6, 9, and 12 months
Conversion Rate to Open Surgery	Rate of patients who required conversion to open surgery	Intraoperative
Primary Patency Rate	Defined as the absence of restenosis > 50% within 30 days	30 days post index procedure
Number of Patients with Clinical Success	Defined by symptom improvement	30 days, 3, 6, 9, and 12 months
Rate of Target Vessel Patency	Absence of restenosis > 50%	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	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	30 days, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
• Investigators: Principal Investigator: Fabio Cypreste Oliveira, Hospital Santa Helena

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID 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