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
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