MARC details
| 000 -LEADER |
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| fixed length control field |
03489nam a22003257a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
210726s20212021 xxu||||| |||| 00| 0 eng d |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1177/11297298211020867 [doi] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
34219511 |
| 245 ## - TITLE STATEMENT |
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| Title |
Intervention with selution SLR TM Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results. |
| 251 ## - Source |
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| Source |
Journal of Vascular Access. :11297298211020867, 2021 Jul 03 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
J. vasc. access. :11297298211020867, 2021 Jul 03 |
| 253 ## - Journal Name |
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| Journal name |
The journal of vascular access |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2021 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2021 Jul 03 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2021-07-26 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR) TM 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 TM to justify its first use in hemodialysis patients for endovascular access salvage. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
DISCUSSION: Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS AND RESULTS: This is an investigator-initiated prospective single-center, non-blinded single-arm trial. Forty patients with clinically significant de novo or recurrent stenoses in a mature AVF circuit will be recruited. All stenotic lesions will be prepared with high pressure non-compliant conventional balloon angioplasty (CBA) prior to deployment of the Sustained-Release Selution TM sirolimus drug-eluting balloon. The primary efficacy endpoint is 6-month target lesion primary patency and the primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days. Secondary endpoints of interest include technical and clinical success rates and circuit access patency at 3 and 6 months. Follow-up will occur for 2 years for those patients whose AVFs remain patent. Pharmacokinetic and histological animal safety studies performed with the Selution TM coating formulation showed prolonged arterial tissue retention of sirolimus with therapeutic levels up to 60 days and non-toxic and rapidly declining blood levels. Histological results in animal models demonstrated safety, freedom from intraluminal thrombus, reduction in restenosis by sirolimus elution compared to CBA, and no evidence of embolic phenomena indicative of adverse particulate effects. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Health Research Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Hellinga, David |
| 790 ## - Authors |
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| All authors |
Barnhill S, Chan SL, Chong TT, DeGraw RT, Finn AV, Hellinga D, Soon SXY, Tan CS, Tan RY, Tang TY, Tay HT, Yap CJQ, Yap HY |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1177/11297298211020867">https://dx.doi.org/10.1177/11297298211020867</a> |
| Public note |
https://dx.doi.org/10.1177/11297298211020867 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
