Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-21

Study Completion Date

2026-08-31

Brief Summary

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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

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Detailed Description

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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

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Vascular Stent - Vesto Endoprosthesis

Vascular Stent Implant - Vesto Endoprosthesis

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No