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

Primary Purpose

Angioplasty, Coronary Artery Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Angioplasty focused on measuring coronary heart disease, large coronary vessel, optical coherence tomography, Drug-coated Balloon, Drug-eluting Stent

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

the Second hospital of Jilin University
The Second Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCB group by OCT guided

DES group by OCT guided

Arm Description

Outcomes

Primary Outcome Measures

late lumen loss （LLL）

late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04664283

First Posted

December 5, 2020

Last Updated

December 5, 2020

Sponsor

Liu Bin

1. Study Identification

Unique Protocol Identification Number

NCT04664283

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liu Bin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angioplasty, Coronary Artery Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

254 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DCB group by OCT guided

Arm Type

Experimental

Arm Title

DES group by OCT guided

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

late lumen loss （LLL）

Description

late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD

Time Frame

Follow-up coronary angiography at 12 months after the procedure

Secondary Outcome Measure Information:

Title

The incidence rate of device-related ischemic events

Description

Time Frame

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

Title

The incidence rate of patient-related ischemic events

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

the Second hospital of Jilin University

City

Chang chun

State/Province

Ji Lin

ZIP/Postal Code

130041

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jinpeng wang, doctor

Phone

15526891295

jinpeng0865@sina.com

Facility Name

The Second Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130041

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30929102

Citation

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.

Results Reference

result

PubMed Identifier

22477748

Citation

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.

Results Reference

result

PubMed Identifier

30366637

Citation

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.

Results Reference

result

PubMed Identifier

30074078

Citation

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.

Results Reference

result

PubMed Identifier

30190206

Citation

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.

Results Reference

result

PubMed Identifier

26627997

Citation

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.

Results Reference

result

PubMed Identifier

27494722

Citation

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.

Results Reference

result

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

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