NCT06573437 Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
| NCT ID | NCT06573437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Braile Biomedica Ind. Com. e Repr. Ltda. |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-21 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-06-21 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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)
Contact & Investigator
Fabio Cypreste Oliveira
PRINCIPAL INVESTIGATOR
Hospital Santa Helena
Frequently Asked Questions
Who can join the NCT06573437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06573437 currently recruiting?
Yes, NCT06573437 is actively recruiting participants. Contact the research team at glaucia.basso@braile.com.br for enrollment information.
Where is the NCT06573437 trial being conducted?
This trial is being conducted at Salvador, Brazil, Goiânia, Brazil, Rio de Janeiro, Brazil, Botucatu, Brazil and 2 additional locations.
Who is sponsoring the NCT06573437 clinical trial?
NCT06573437 is sponsored by Braile Biomedica Ind. Com. e Repr. Ltda.. The principal investigator is Fabio Cypreste Oliveira at Hospital Santa Helena. The trial plans to enroll 100 participants.