Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
NCT ID: NCT04664283
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
254 participants
INTERVENTIONAL
2021-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCB group by OCT guided
DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
DES group by OCT guided
DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
Interventions
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DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Reference vessel diameter ≥3.0 mm, and \<4.5mm. Lesion length of ≤20 mm Written informed consent
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Liu Bin
OTHER
Responsible Party
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Liu Bin
Director of cardiology department.
Locations
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The Second Hospital of Jilin University
Changchun, Jilin, China
the Second hospital of Jilin University
Changchun, Jilin, China
Countries
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Facility Contacts
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jinpeng wang, doctor
Role: primary
References
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Liu Y, Zhang YJ, Deng LX, Yin ZY, Hu T, Wang Q, Li Y, Li JY, Guo WY, Mou FJ, Tao L. 12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm. Int J Cardiovasc Imaging. 2019 Apr;35(4):579-586. doi: 10.1007/s10554-018-1505-z. Epub 2019 Mar 30.
Cuculi F, Young M, Beeler R, Schoenenberger AW, Erne P. Good efficacy of drug-eluting balloons in a mixed population of patients with coronary artery disease. J Invasive Cardiol. 2012 Apr;24(4):151-3.
Lu W, Zhu Y, Han Z, Sun G, Qin X, Wang Z, Liu G, Xi W, Wang X, Pan L, Qiu C. Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels. J Cardiol. 2019 Feb;73(2):151-155. doi: 10.1016/j.jjcc.2018.07.008. Epub 2018 Oct 23.
Yu X, Ji F, Xu F, Zhang W, Wang X, Lu D, Yang C, Wang F. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019 Mar;108(3):234-243. doi: 10.1007/s00392-018-1346-8. Epub 2018 Aug 3.
Lansky A, Wijns W, Xu B, Kelbaek H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schachinger V, Baumbach A; TARGET All Comers Investigators. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial. Lancet. 2018 Sep 29;392(10153):1117-1126. doi: 10.1016/S0140-6736(18)31649-0. Epub 2018 Sep 3.
Cortese B, Silva Orrego P, Agostoni P, Buccheri D, Piraino D, Andolina G, Seregni RG. Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection. JACC Cardiovasc Interv. 2015 Dec 28;8(15):2003-2009. doi: 10.1016/j.jcin.2015.08.029. Epub 2015 Nov 25.
Nishiyama N, Komatsu T, Kuroyanagi T, Fujikake A, Komatsu S, Nakamura H, Yamada K, Nakahara S, Kobayashi S, Taguchi I. Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease. Int J Cardiol. 2016 Nov 1;222:113-118. doi: 10.1016/j.ijcard.2016.07.156. Epub 2016 Jul 27.
Other Identifiers
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second hospital of Jilin U
Identifier Type: -
Identifier Source: org_study_id