Drug-coated Balloon
Conditions
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.
Interventions
DEVICEdrug-coated balloon
drug-coated balloon
Sponsors
Ulsan Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- de novo coronary artery disease
Exclusion criteria
* unstable hemodynamics at presentation * life expectancy \<1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactEun-Seok Shin
Outcome results
None listed