Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion

NCT ID: NCT04619277

Last Updated: 2024-08-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-22

Study Completion Date

2030-12-31

Brief Summary

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

Detailed Description

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There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.

Conditions

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Drug-coated Balloon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Ulsan Medical Center

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Queen Elizabeth Hospital

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Pecking University Shougand Hospital

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Ulsan University Hospital

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Kangwon National University School of Medicine

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Korea University Guro Hospital

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Korea University Ansan Hospital

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

drug-coated balloon

Intervention Type DEVICE

drug-coated balloon

Interventions

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drug-coated balloon

drug-coated balloon

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- de novo coronary artery disease

Exclusion Criteria

* unstable hemodynamics at presentation
* life expectancy \<1 year
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eun-Seok Shin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo-Jin Kim

Role: PRINCIPAL_INVESTIGATOR

IRB

Locations

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Ulsan Medical Center

Ulsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eun-Seok Shin

Role: CONTACT

Facility Contacts

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Eun-Seok Shin

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39840648 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37210516 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36609038 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35498010 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34672131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33251774 (View on PubMed)

Other Identifiers

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USH-20-004

Identifier Type: REGISTRY

Identifier Source: secondary_id

USH-20-004

Identifier Type: -

Identifier Source: org_study_id

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