Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Angioplasty
• Intervention / Treatment: Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

• Study Type: Interventional
• Enrollment (Anticipated): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ji Lin
    • Chang chun, Ji Lin, China, 130041
      • The Second Hospital of Jilin University
      • Contact: jinpeng wang, doctor; Phone Number: 15526891295; Email: jinpeng0865@sina.com
  • Jilin
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .

Reference vessel diameter ≥3.0 mm, and <4.5mm. Lesion length of ≤20 mm Written informed consent

Exclusion Criteria:

Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB group by OCT guided	Device: 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 Names: DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
Active Comparator: DES group by OCT guided	Device: 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 Names: DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss （LLL）	late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD	Follow-up coronary angiography at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of device-related ischemic events	The incidence rate of device-related ischemic events including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization between DCB treated group and DES treated group	Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure
The incidence rate of patient-related ischemic events	TThe incidence rate of patient-related ischemic events including all myocardial infarction , any revascularization and all-cause death between DCB treated group and DES treated group	Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure

Collaborators and Investigators

• Sponsor: Liu Bin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 5, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: optical coherence tomography; Drug-coated Balloon; Drug-eluting Stent; coronary heart disease; large coronary vessel
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: second hospital of Jilin U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No