A study to evaluate the safety and feasibility of a new drug-coated balloon treatment for patients with coronary artery narrowing

ISRCTN	ISRCTN16327473
DOI	https://doi.org/10.1186/ISRCTN16327473
Sponsor	Korea Health Industry Development Institute
Funder	Kangdong Sacred Heart Hospital, Hallym University

Submission date: 17/11/2025
Registration date: 20/11/2025
Last edited: 20/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Coronary artery disease occurs when the blood vessels supplying the heart become narrowed, which can reduce blood flow. A drug-coated balloon is a special device that delivers medication directly to the artery to help keep it open without leaving a permanent implant. This study aims to assess whether a new drug-coated balloon (GENOSS DCB) is safe and effective for treating patients with newly developed coronary artery narrowing.

Who can participate?
Adults aged 19 years or older with a newly diagnosed narrowing of a coronary artery that requires balloon treatment during a heart procedure may be eligible. People who have recently had a major heart attack, have severe heart weakness, severe kidney disease, or certain complex artery stenosis will not be able to take part.

What does the study involve?
Participants undergo a standard heart procedure called percutaneous coronary intervention. The narrowed artery is first opened with a regular balloon. If this is successful, the study device (GENOSS DCB) is inflated for 60 seconds to deliver medication to the artery wall. Participants then receive standard heart medications and return for routine follow-up visits, including a repeat angiogram at 6 months to check how the artery has healed.

What are the possible benefits and risks of participating?
Participants may benefit from the treatment of their coronary artery narrowing without receiving a permanent stent. Risks are similar to those of routine balloon procedures and may include bleeding, temporary vessel injury, or discomfort. Some participants may not experience direct benefits, but their involvement can help improve future heart treatments for others.

Where is the study run from?
The study is conducted at Hallym University Kangnam Sacred Heart Hospital and Yonsei University Severance Hospital in South Korea.

When is the study starting and how long is it expected to run for?
January 2023 to December 2023.

Who is funding the study?
The study is supported as part of a health-industry collaborative project in Korea. No commercial company is directly funding this research.

Who is the main contact?
Dr Jung Rae Cho, Division of Cardiology, Kangnam Sacred Heart Hospital, jrjoe@naver.com

Contact information

Prof Jung Rae Cho
Principal investigator, Scientific, Public

Cardiology Division, Department of Internal Medicine
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
1 Singil-ro, Yeongdeungpo-gu
Seoul
07441
Korea, South

ORCID ID	0000-0002-9803-6612
Phone	+82 10 9256 9440
Email	jrjoe@naver.com

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Device feasibility, Treatment
Participant information sheet	48507_PIS_v1.1[English].pdf
Scientific title	Clinical feasibility and safety of a novel paclitaxel-coated balloon using shellac and vitamin E excipient for the treatment of de novo coronary artery lesions: a prospective, single-arm pilot study
Study objectives	The study aims to evaluate the clinical feasibility, safety, and angiographic efficacy of the GENOSS paclitaxel-coated balloon using a shellac plus vitamin E excipient in patients with de novo coronary artery lesions. The primary objective is to assess in-segment late lumen loss at 6 months following drug-coated balloon angioplasty. Secondary objectives include evaluating changes in minimal lumen diameter, diameter stenosis, restenosis rate, and the incidence of major adverse cardiac events.
Ethics approval(s)	1. Approved 01/01/2023, Hallym University Kangnam Sacred Heart Hospital Institutional Review Board (1 Singil-ro, Yeongdeungpo-gu, Seoul, 07441, Korea, South; + 82-2-829-5193; knsh_irb@hallym.or.kr), ref: 2022-12-001 2. Approved 01/01/2023, Yonsei University Health system, Severance Hospital Institutional Review Board (Yonsei University Health System, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea, South; +82-2-2228-0415; irb@yuhs.ac), ref: 1-2022-0088
Health condition(s) or problem(s) studied	De novo coronary artery lesions requiring percutaneous coronary intervention
Intervention	Participants undergo percutaneous coronary intervention with the GENOSS paclitaxel-coated balloon, which contains paclitaxel 3 µg/mm² with a shellac plus vitamin E excipient. All eligible lesions are first pre-dilated with a standard balloon catheter sized 1:1 to the reference vessel diameter. If predilation is successful with residual stenosis ≤ 30% and TIMI flow grade 3, the GENOSS drug-coated balloon is inflated at nominal pressure for 60 seconds to deliver the antiproliferative drug to the vessel wall. No control or comparator treatment is used, as the study follows a single-arm design. Participants continue to receive standard medical therapy, including aspirin and a P2Y12 inhibitor, for up to 6 months after the procedure. Follow-up visits are performed at 1 month and 6 months, with repeat coronary angiography at 6 months to evaluate angiographic outcomes.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	GENOSS Paclitaxel-Coated Balloon (paclitaxel 3 µg/mm² with shellac plus vitamin E excipient)
Primary outcome measure(s)	In-segment late lumen loss measured using quantitative coronary angiography (QCA) of the change in minimal lumen diameter within the treated segment at 6 months after the index procedure
Key secondary outcome measure(s)	Minimal lumen diameter of the treated segment measured using quantitative coronary angiography (QCA) at baseline, post-pre-dilation, post-DCB, and 6 months after the index procedure Diameter stenosis of the treated segment measured using quantitative coronary angiography (QCA) at baseline, post-pre-dilation, post-DCB, and 6 months after the index procedure Binary restenosis rate (diameter stenosis ≥ 50%) measured using quantitative coronary angiography determining percentage diameter stenosis at 6 months after the index procedure Major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, or target vessel revascularization) measured using clinical event adjudication based on standardized definitions at 6 months after the index procedure
Completion date	05/12/2023

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	19 Years
Upper age limit	120 Years
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	1. Adults aged ≥ 19 years. 2. Patients with de novo coronary artery lesions requiring percutaneous coronary intervention. 3. Target vessel diameter between 2.0 mm and 4.0 mm on coronary angiography. 4. Successful predilation with residual stenosis ≤ 30% and TIMI flow grade = 3. 5. Ability and willingness to provide written informed consent.
Key exclusion criteria	1. ST-segment elevation myocardial infarction (STEMI) within the previous 48 hours. 2. Cardiogenic shock or hemodynamic instability. 3. Left ventricular ejection fraction < 30%. 4. Severe renal impairment (eGFR < 30 mL/min/1.73 m²). 5. Known contraindication or suspected intolerance to paclitaxel, aspirin, or P2Y12 inhibitors. 6. Life expectancy less than 1 year due to non-cardiac comorbidities. 7. Pregnancy or lactation. 8. In-stent restenosis lesions. 9. Bypass graft lesions. 10. Chronic total occlusions (CTO). 11. Left main coronary artery disease. 12. Failure of predilation defined as residual stenosis > 30% or TIMI flow < 3 after balloon angioplasty.
Date of first enrolment	04/01/2023
Date of final enrolment	25/07/2023

Locations

Countries of recruitment

Korea, South

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1.1		20/11/2025	No	Yes
Participant information sheet	version 1.1		20/11/2025	No	Yes
Protocol file	version 1.1	14/10/2022	20/11/2025	No	No

Additional files

48507_PIS_v1.1[English].pdf: Participant information sheet
48507_PIS_v1.1[Korean].pdf: Participant information sheet
48507_Protocol_v1.1_14Oct2022.pdf: Protocol file

Editorial Notes

20/11/2025: Study’s existence confirmed by the Institutional Review Board of Hallym University Kangnam Sacred Heart Hospital, Korea.