Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease
Megadott ok: Low recruitment potential, limiting the feasibility of achieving the planned sample size.
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A vizsgálat adatai
- Ki végzi
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Azonosító
- NCT06573437
- A regiszteradat frissítve
- 2026. november 2.
- Eredeti leírás
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 trialA teljes eredeti leírásKevesebb
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
Bevonási feltételek: 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.
Kizáró feltételek: Patient currently participating in an investigational drug or device study; Patient undergoing chemotherapy or radiation therapy; Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study; Inability to undergo dual antiplatelet therapy (DAPT); Known hypersensitivity to heparin, contrast media, or stent components; Patient with blood dyscrasia; Pregnant or breastfeeding women; Patient with a stent or graft located in the target limb; Patient with a life expectancy of less than 12 months.