Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results.
AuthorTang, Tjun Yip
Yap, Charyl Jia Qi
Soon, Shereen Xue Yun
Chan, Sze Ling
Tan, Ru Yu
Yap, Hao Yun
Tay, Hsien Ts'ung
DeGraw, R Tyler
Finn, Aloke V
JournalJournal of Vascular Access
PublisherSAGE Publications Inc.
MetadataShow full item record
AbstractThe aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage.
KeywordSirolimus coated balloon
pre-clinical animal model
target lesion primary patency
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/16191
- Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial.
- Authors: Tang TY, Soon SX, Yap CJ, Tan RY, Pang SC, Patel A, Gogna A, Tan CS, Chong TT
- Issue date: 2021 Dec 30
- Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions.
- Authors: Zeller T, Brechtel K, Meyer DR, Noory E, Beschorner U, Albrecht T
- Issue date: 2020 Oct
- SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial.
- Authors: Pang SC, Tan RY, Choke E, Ho J, Tay KH, Gogna A, Irani FG, Zhuang KD, Toh L, Chan S, Krishnan P, Lee KA, Leong S, Lo R, Patel A, Tan BS, Too CW, Chua J, Tng RKA, Tang TY, Chng SP, Chong TT, Tay HT, Yap HY, Wong J, Dharmaraj RB, Ng JJ, Gopinathan A, Loh EK, Ong SJ, Yoong G, Tay JS, Chong KY, Tan CS
- Issue date: 2021 Dec 20
- World's First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study.
- Authors: Tang TY, Yap C, Soon SXY, Chan SL, Lee QS, Yap HY, Tay HTL, Chong TT
- Issue date: 2021 Aug
- Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial.
- Authors: Tang TY, Soon SXY, Yap CJQ, Chan SL, Tan RY, Pang SC, Lee SQW, Yap HY, Choke ETC, Tan CS, Chong TT
- Issue date: 2020