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Introduction: Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-coated balloon (DCB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with renal artery stenosis. And PTA for Renal artery fibromuscular dysplasia is safe and clinically successful. Therefore, we could speculate that DCB might have potential efficacy in non-atherosclerotic RAS treatment.

Methods and Analysis: This will be a randomized multi-center-controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (plain old balloon, POB) and the experimental group (DCB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DCB angioplasty. The DCB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include controlled blood pressure and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate.

Trial Registration: ClinicalTrials.gov (number NCT05858190). Protocol version V.4 (3 May 2023).

Titel:	Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis-a multi-center study.
Autor/in / Beteiligte Person:	Song, X ; Fu, Y ; Lai, Z ; Di, X ; Zeng, R ; Shao, J ; Ni, L ; Liu, Z ; Ye, W ; Liu, C ; Liu, B ; Zheng, Y ; Chen, Y
Link:	View record at Springer (Volltext)
Zeitschrift:	BMC cardiovascular disorders, Jg. 23 (2023-10-16), Heft 1, S. 510
Veröffentlichung:	London : BioMed Central, [2001-, 2023
Medientyp:	academicJournal
ISSN:	1471-2261 (electronic)
DOI:	10.1186/s12872-023-03484-5
Schlagwort:	Humans Coated Materials, Biocompatible Femoral Artery Paclitaxel adverse effects Popliteal Artery Prospective Studies Time Factors Treatment Outcome Vascular Patency Randomized Controlled Trials as Topic Multicenter Studies as Topic Angioplasty, Balloon adverse effects Peripheral Arterial Disease diagnostic imaging Peripheral Arterial Disease therapy Renal Artery Obstruction diagnostic imaging Renal Artery Obstruction etiology Renal Artery Obstruction therapy
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't Language: English [BMC Cardiovasc Disord] 2023 Oct 16; Vol. 23 (1), pp. 510. <i>Date of Electronic Publication: </i>2023 Oct 16. MeSH Terms: Angioplasty, Balloon* / adverse effects ; Peripheral Arterial Disease* / diagnostic imaging ; Peripheral Arterial Disease* / therapy ; Renal Artery Obstruction* / diagnostic imaging ; Renal Artery Obstruction* / etiology ; Renal Artery Obstruction* / therapy ; Humans ; Coated Materials, Biocompatible ; Femoral Artery ; Paclitaxel / adverse effects ; Popliteal Artery ; Prospective Studies ; Time Factors ; Treatment Outcome ; Vascular Patency ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic References: Eur J Radiol. 2017 Jun;91:106-115. (PMID: 28629556) ; J Manag Care Spec Pharm. 2021 Aug;27(8):971-981. (PMID: 34337985) ; J Am Coll Cardiol. 2015 Dec 8;66(22):2487-94. (PMID: 26653621) ; Pediatr Nephrol. 2007 Sep;22(9):1327-33. (PMID: 17534666) ; Am J Med Sci. 2013 Sep;346(3):244-6. (PMID: 23538936) ; Clin Res Cardiol. 2016 Nov;105(11):930-937. (PMID: 27270759) ; JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. (PMID: 27539695) ; Eur Heart J. 2018 Mar 1;39(9):763-816. (PMID: 28886620) ; EuroIntervention. 2017 Jun 2;13(2):e248-e255. (PMID: 28044987) ; Nephron. 1992;62(3):249-56. (PMID: 1436333) ; J Vasc Interv Radiol. 2002 Oct;13(10):959-74. (PMID: 12397117) ; Catheter Cardiovasc Interv. 2019 Jul 1;94(1):139-148. (PMID: 30838719) ; Circulation. 2018 Oct 23;138(17):e426-e483. (PMID: 30354655) ; N Engl J Med. 2014 Jan 2;370(1):13-22. (PMID: 24245566) ; Acta Paediatr. 1992 Mar;81(3):244-6. (PMID: 1511199) ; Diagn Interv Radiol. 2014 May-Jun;20(3):285-92. (PMID: 24675165) ; Cardiol Young. 2015 Oct;25(7):1431-4. (PMID: 25296292) ; Ann Transplant. 2018 Jan 26;23:75-80. (PMID: 29371586) ; N Engl J Med. 2009 Nov 12;361(20):1972-8. (PMID: 19907044) ; Hypertension. 2010 Sep;56(3):525-32. (PMID: 20625080) ; Urol Clin North Am. 1984 Aug;11(3):529-42. (PMID: 6380081) ; Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. (PMID: 11904577) Contributed Indexing: Keywords: Angioplasty; Balloon; Hypertension; Renal artery obstruction; Research design; Treatment outcome Molecular Sequence: ClinicalTrials.gov NCT05858190 Substance Nomenclature: 0 (Coated Materials, Biocompatible) ; P88XT4IS4D (Paclitaxel) Entry Date(s): Date Created: 20231016 Date Completed: 20231103 Latest Revision: 20231121 Update Code: 20231215 PubMed Central ID: PMC10577992

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Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis-a multi-center study.