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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16327473

Enrollment

Registered

2025-11-20

Start date

2023-01-04

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

De novo coronary artery lesions requiring percutaneous coronary intervention Circulatory System

Interventions

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

Eligibility

Sex/Gender

All

Age

19 Years to 120 Years

Inclusion criteria

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.

Exclusion criteria

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% or TIMI flow < 3 after balloon angioplasty.

Countries

Korea, South

Contacts

Public ContactJung Rae Cho

jrjoe@naver.com+82 10 9256 9440

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026