USE of IMplanting the Biotronik PassEo-18 Lux drug coated balloon to treat failing haemodialysis arteRiovenous FIstulas and grafts (SEMPER FI Study).

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Tác giả: Dexter Yak Seng Chan, Shaun Wen Yang Chan, Tze Gek Ho, Chuo Ren Leong, Tjun Yip Tang, Charyl Jia Qi Yap, Hao Yun Yap

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : The journal of vascular access , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 581806

BACKGROUND: Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm METHODS: The USE of IMplanting the Biotronik PassEo-18 Lux DCB to treat failing haemodialysis arteRiovenous FIstulas and grafts trial (SEMPER FI) was a prospective double-centre, multi-investigator, non-consecutive, non-blinded single-arm study investigating the efficacy and safety of the Passeo-18 Lux DCB in patients with stenotic AVF/AVG lesions between January 2021 and January 2022. Patient demographics, clinical characteristics, vascular access history, operative indications, details and outcomes were collected prospectively. TLPP, circuit access primary patency (CAP), PP, SP and deaths 6- and 12-months post-intervention were studied. RESULTS: Ninety-one patients with 110 lesions were recruited across the two centres. 62.6% ( CONCLUSION: This study shows that the Passeo-18 Lux DCB can be an effective and safe tool in the treatment of failing haemodialysis AVFs/AVGs.
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