Clinical trial NCT06573437: Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
Official title: Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of Device-Related Serious Adverse Events (Device Safety)
timeFrame: 30 days post-index procedure
measure: Number of Patients with Technical Success (Device Performance)
timeFrame: Intraoperative
measure: Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)
timeFrame: 30 days post index procedure
Secondary outcomes:
measure: Rate of Technical Success
timeFrame: Intraoperative
measure: Rate of Procedural Success
timeFrame: 30 days post index procedure
measure: Incidence of Adverse Events
timeFrame: 30 days, 3, 6, 9, and 12 months
measure: Conversion Rate to Open Surgery
timeFrame: Intraoperative
measure: Primary Patency Rate
timeFrame: 30 days post index procedure
measure: Number of Patients with Clinical Success
timeFrame: 30 days, 3, 6, 9, and 12 months
measure: Rate of Target Vessel Patency
timeFrame: 3, 6, 9, and 12 months
measure: Limb Salvage Rate
timeFrame: 30 days, 6, 9, and 12 months
measure: Need for Endovascular Reintervention at the Target Lesion
timeFrame: 30 days, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital Ana Nery
state: BA
city: Goiânia
country: Brazil
facility: Hospital Santa Helena
state: GO
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto (HUPE-UERJ)
state: RJ
city: Botucatu
country: Brazil
facility: HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista
state: SP
city: Campinas
country: Brazil
facility: Hospital de Clínicas da Universidade Estadual de Campinas
state: SP
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
state: SP
Study officials:
affiliation: Hospital Santa Helena
name: Fabio Cypreste Oliveira
role: PRINCIPAL_INVESTIGATOR
References: