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Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft

BACKGROUND: In arteriovenous graft (AVG) for haemodialysis, the primary cause of failure is venous stenosis of the graft-vein junction from neointimal hyperplasia (NIH), resulting in thrombosis. While interventions to salvage clotted AVG are known to have high clinical success rates, long-term paten...

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Autores principales: Tan, Ru Yu, Tan, Chee Wooi, Pang, Suh Chien, Foo, Marjorie Wai Yin, Tang, Tjun Yip, Gogna, Apoorva, Chong, Tze Tec, Tan, Chieh Suai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335758/
https://www.ncbi.nlm.nih.gov/pubmed/32627114
http://dx.doi.org/10.1186/s42155-020-00123-4
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author Tan, Ru Yu
Tan, Chee Wooi
Pang, Suh Chien
Foo, Marjorie Wai Yin
Tang, Tjun Yip
Gogna, Apoorva
Chong, Tze Tec
Tan, Chieh Suai
author_facet Tan, Ru Yu
Tan, Chee Wooi
Pang, Suh Chien
Foo, Marjorie Wai Yin
Tang, Tjun Yip
Gogna, Apoorva
Chong, Tze Tec
Tan, Chieh Suai
author_sort Tan, Ru Yu
collection PubMed
description BACKGROUND: In arteriovenous graft (AVG) for haemodialysis, the primary cause of failure is venous stenosis of the graft-vein junction from neointimal hyperplasia (NIH), resulting in thrombosis. While interventions to salvage clotted AVG are known to have high clinical success rates, long-term patency rates have been suboptimal. Drug-coated balloon (DCB) has been used to treat stenosed arteriovenous access in recent years with encouraging results but data on its effect in clotted AVG is unavailable. METHODS: This is an investigator-initiated, single-center, single-arm prospective pilot study to determine the safety and outcome of the sirolimus-coated balloon (SCB) in the salvage of thrombosed AVG. Twenty patients who undergo successful percutaneous thrombectomy will receive treatment with SCB at the graft vein junction. The patients will be followed-up for 6-months. The primary endpoint is the patency rates at 3-month while the secondary endpoints are the patency rates and the number of interventions needed to maintain patency at 6-month. DISCUSSION: Unremitting efforts have been made to prolong the patency of AV accesses over the years. DCB angioplasty combines mechanical and biological treatment for vascular stenosis. Sirolimus, being a cystostatic anti-proliferative agent, has been successfully used in coronary artery interventions. As the primary pathology of vascular stenosis in the dialysis circuit is neointimal hyperplasia, the use of sirolimus in balloon angioplasty may be effective. With this prospective study, we evaluate the efficacy and safety of SCB in patients with clotted AVG. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03666208 on 11 September 2018.
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spelling pubmed-73357582020-07-09 Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft Tan, Ru Yu Tan, Chee Wooi Pang, Suh Chien Foo, Marjorie Wai Yin Tang, Tjun Yip Gogna, Apoorva Chong, Tze Tec Tan, Chieh Suai CVIR Endovasc Study Protocol BACKGROUND: In arteriovenous graft (AVG) for haemodialysis, the primary cause of failure is venous stenosis of the graft-vein junction from neointimal hyperplasia (NIH), resulting in thrombosis. While interventions to salvage clotted AVG are known to have high clinical success rates, long-term patency rates have been suboptimal. Drug-coated balloon (DCB) has been used to treat stenosed arteriovenous access in recent years with encouraging results but data on its effect in clotted AVG is unavailable. METHODS: This is an investigator-initiated, single-center, single-arm prospective pilot study to determine the safety and outcome of the sirolimus-coated balloon (SCB) in the salvage of thrombosed AVG. Twenty patients who undergo successful percutaneous thrombectomy will receive treatment with SCB at the graft vein junction. The patients will be followed-up for 6-months. The primary endpoint is the patency rates at 3-month while the secondary endpoints are the patency rates and the number of interventions needed to maintain patency at 6-month. DISCUSSION: Unremitting efforts have been made to prolong the patency of AV accesses over the years. DCB angioplasty combines mechanical and biological treatment for vascular stenosis. Sirolimus, being a cystostatic anti-proliferative agent, has been successfully used in coronary artery interventions. As the primary pathology of vascular stenosis in the dialysis circuit is neointimal hyperplasia, the use of sirolimus in balloon angioplasty may be effective. With this prospective study, we evaluate the efficacy and safety of SCB in patients with clotted AVG. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03666208 on 11 September 2018. Springer International Publishing 2020-07-05 /pmc/articles/PMC7335758/ /pubmed/32627114 http://dx.doi.org/10.1186/s42155-020-00123-4 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Study Protocol
Tan, Ru Yu
Tan, Chee Wooi
Pang, Suh Chien
Foo, Marjorie Wai Yin
Tang, Tjun Yip
Gogna, Apoorva
Chong, Tze Tec
Tan, Chieh Suai
Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
title Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
title_full Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
title_fullStr Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
title_full_unstemmed Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
title_short Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
title_sort study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335758/
https://www.ncbi.nlm.nih.gov/pubmed/32627114
http://dx.doi.org/10.1186/s42155-020-00123-4
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