NCT04619277

Brief Summary

This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Apr 2011Dec 2030

Study Start

First participant enrolled

April 22, 2011

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

19.7 years

First QC Date

October 29, 2020

Last Update Submit

August 12, 2024

Conditions

Drug-coated Balloon

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events at 12 months

    Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding \[BARC type 3 to 5\]) at 12 months. 1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.

    12 months

Secondary Outcomes (1)

  • Angiographic and clinical outcomes

    12, 24, 36 months

Study Arms (7)

Ulsan Medical Center

Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea

Device: drug-coated balloon

Queen Elizabeth Hospital

Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia

Device: drug-coated balloon

Pecking University Shougand Hospital

Department of Cardiology, Peking University Shougang Hospital, Peking, China

Device: drug-coated balloon

Ulsan University Hospital

Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea

Device: drug-coated balloon

Kangwon National University School of Medicine

Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea

Device: drug-coated balloon

Korea University Guro Hospital

Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea

Device: drug-coated balloon

Korea University Ansan Hospital

Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea

Device: drug-coated balloon

Interventions

drug-coated balloonDEVICE

drug-coated balloon

Kangwon National University School of MedicineKorea University Ansan HospitalKorea University Guro HospitalPecking University Shougand HospitalQueen Elizabeth HospitalUlsan Medical CenterUlsan University Hospital

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It is a international multicenter registry study conducted at 4 centers (Queen Elizabeth Hospital II, Peking Shougang Hospital, Ulsan Medical Center, and Ulsan University Hospital) expert in patients with de novo coronary lesion who received DCB treatment.

You may qualify if:

  • \- de novo coronary artery disease

You may not qualify if:

  • unstable hemodynamics at presentation
  • life expectancy \<1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan Medical Center

Ulsan, 44686, South Korea

RECRUITING

Related Publications (7)

  • Her AY, Kim S, Kang DO, Sohn CB, Kim YH, Kim B, Shin ES. Drug-Coated Balloon-Based Intervention for De Novo Acute Myocardial Infarction. Yonsei Med J. 2025 Dec;66(12):807-815. doi: 10.3349/ymj.2024.0524.

    PMID: 41287492DERIVED

  • Her AY, Kim TH, Shin ES, Kim S, Kim B, Kim YH, Choi KH, Cho YK, Lee HJ, Song YB, Nam CW, Gwon HC. Drug-Coated Balloon-Based Treatment of Left Main True Bifurcation Lesion. Catheter Cardiovasc Interv. 2025 Apr;105(5):1024-1031. doi: 10.1002/ccd.31416. Epub 2025 Jan 22.

    PMID: 39840648DERIVED

  • Her AY, Shin ES, Kim S, Kim B, Kim TH, Sohn CB, Choi BJ, Park Y, Cho JR, Jeong YH. Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease. Cardiovasc Diabetol. 2023 May 20;22(1):120. doi: 10.1186/s12933-023-01853-0.

    PMID: 37210516DERIVED

  • Shin ES, Jun EJ, Kim S, Kim B, Kim TH, Sohn CB, Her AY, Park Y, Cho JR, Jeong YH, Choi BJ. Clinical Impact of Drug-Coated Balloon-Based Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease. JACC Cardiovasc Interv. 2023 Feb 13;16(3):292-299. doi: 10.1016/j.jcin.2022.10.049. Epub 2023 Jan 4.

    PMID: 36609038DERIVED

  • Jun EJ, Shin ES, Teoh EV, Bhak Y, Yuan SL, Chu CM, Garg S, Liew HB. Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions. Front Cardiovasc Med. 2022 Apr 13;9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.

    PMID: 35498010DERIVED

  • Kun L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Hui L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease. Yonsei Med J. 2021 Nov;62(11):981-989. doi: 10.3349/ymj.2021.62.11.981.

    PMID: 34672131DERIVED

  • Hui L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Kun L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes. Yonsei Med J. 2020 Dec;61(12):1004-1012. doi: 10.3349/ymj.2020.61.12.1004.

    PMID: 33251774DERIVED

Study Officials

  • Soo-Jin Kim

    IRB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun-Seok Shin

CONTACT

sesim1989@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 6, 2020

Study Start

April 22, 2011

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

KR(1)