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

Recruiting

• Conditions: 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.

Study Timeline

• Study Start: 2011-04-22
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• de novo coronary artery disease

Exclusion Criteria

• unstable hemodynamics at presentation
• life expectancy <1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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