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

Drug-coated Balloon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619277
• Other study ID #: USH-20-004
• Secondary ID: USH-20-004
• Status: Recruiting
• Start date: April 22, 2011
• Est. completion date: December 31, 2030

Study information

• Verified date: August 2021
• Source: Ulsan Medical Center
• Contact: Eun-Seok Shin
• Email: sesim1989[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• de novo coronary artery disease

Exclusion Criteria:

• unstable hemodynamics at presentation

• life expectancy <1 year

Related Conditions & MeSH terms

• Drug-coated Balloon

Intervention

Device:
• drug-coated balloon
drug-coated balloon

Locations

Country	Name	City	State
Korea, Republic of	Ulsan Medical Center	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 ? 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 ? DAPT duration ? Periprocedural MI rate ? Sex difference in MACE between DCB vs. DES ? Comparison of MACE between DCB vs. DES in DM patients	12, 24, 36 months