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

Study Overview
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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.

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

Conditions
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Drug-coated Balloon

Intervention / Treatment
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* Device: drug-coated balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - de novo coronary artery disease Exclusion Criteria: unstable hemodynamics at presentation life expectancy <1 year
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulsan Medical Center<br>Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea | Device: drug-coated balloon<br>* drug-coated balloon<br>|
| Queen Elizabeth Hospital<br>Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia | Device: drug-coated balloon<br>* drug-coated balloon<br>|
| Pecking University Shougand Hospital<br>Department of Cardiology, Peking University Shougang Hospital, Peking, China | Device: drug-coated balloon<br>* drug-coated balloon<br>|
| Ulsan University Hospital<br>Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea | Device: drug-coated balloon<br>* drug-coated balloon<br>|
| Kangwon National University School of Medicine<br>Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea | Device: drug-coated balloon<br>* drug-coated balloon<br>|
| Korea University Guro Hospital<br>Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea | Device: drug-coated balloon<br>* drug-coated balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic and clinical outcomes | MACE at 12, 24, 36 months The single components of the primary endpoint after 12, 24, 36 months. Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding after 12, 24, 36 months.1 (All events will be adjudicated by an independent Critical Events Committee). Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, 36 months. Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation Cost-effectiveness of DCB vs. DES after 12, 24, 36 months. All-cause death ⑥ Stroke (ischemic and hemorrhagic) Angina severity measured with Seattle Angina Questionnaires at 12, 24 months Total procedure time, fluoroscopy time, contrast volume, number of stents used ⑨ DAPT duration ⑩ Periprocedural MI rate ⑪ Sex difference in MACE between DCB vs. DES ⑫ Comparison of MACE between DCB vs. DES in DM patients | 12, 24, 36 months |