Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
- Conditions
- Drug-coated Balloon
- Interventions
- Device: drug-coated balloon
- Registration Number
- NCT04619277
- Lead Sponsor
- Ulsan Medical Center
- Brief Summary
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- de novo coronary artery disease
- unstable hemodynamics at presentation
- life expectancy <1 year
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kangwon National University School of Medicine drug-coated balloon Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea Korea University Ansan Hospital drug-coated balloon Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea Queen Elizabeth Hospital drug-coated balloon Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia Pecking University Shougand Hospital drug-coated balloon Department of Cardiology, Peking University Shougang Hospital, Peking, China Korea University Guro Hospital drug-coated balloon Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea Ulsan Medical Center drug-coated balloon Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea Ulsan University Hospital drug-coated balloon Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
- Primary Outcome Measures
Name Time Method Major adverse cardiac events at 12 months 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.
- Secondary Outcome Measures
Name Time Method Angiographic and clinical outcomes 12, 24, 36 months * 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
Trial Locations
- Locations (1)
Ulsan Medical Center
🇰🇷Ulsan, Korea, Republic of