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

NCT04664283 | Unknown

• 1 other identifier: second hospital of Jilin U
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Angioplasty; Coronary Artery Disease

Keywords

coronary heart disease; large coronary vessel; optical coherence tomography; Drug-coated Balloon; Drug-eluting Stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The incidence rate of device-related ischemic events

  Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure

• The incidence rate of patient-related ischemic events

  Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure

Study Arms (2)

DCB group by OCT guided

EXPERIMENTAL

Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

DES group by OCT guided

ACTIVE COMPARATOR

Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

Interventions

DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography DEVICE

DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography

Also known as: DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

DCB group by OCT guided; DES group by OCT guided

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liu Bin: lead

Study Sites (2)

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

the Second hospital of Jilin University

Changchun, Jilin, 130041, China

Location

Related Publications (7)

• 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.

  PMID: 30929102 RESULT

• 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.

  PMID: 22477748 RESULT

• 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.

  PMID: 30366637 RESULT

• 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.

  PMID: 30074078 RESULT

• 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.

  PMID: 30190206 RESULT

• 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.

  PMID: 26627997 RESULT

• 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.

  PMID: 27494722 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of cardiology department.

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)