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Clinical Trials in South Korea / NCT05656118
Active, not recruiting Observational

Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)

NCT05656118 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Observational
Started
2022-08-31
Last updated
2025-07-08

Condition(s) studied

In-stent Restenosis

Investigational drug(s) / intervention(s)

Genoss® DCB

Genoss® DCB: Paclitaxel coated balloon with a shellac plus vitamin E excipient

Study summary

The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.

The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: ① Age ≥18 years old. ② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients. ③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent. Exclusion Criteria: * A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months. * Patients with life expectancy less than 1 year. * Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment. * Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.

Primary outcome measure(s)

  • Targeted lesion failure — 12 months
    A composite of cardiac death, target-vessel MI, or target lesion revascularization

Trial sites (10)

FacilityCityRegionStatus
Kosin University Gospel Hospital Busan Busan
Kangwon National University Hospital Chuncheon Gangwon-do
Korea University Ansan Hospital Ansan-si Gyeonggi-do
Inje University Ilsan Paik Hospital Goyang-si Gyeonggi-do
National Health Insurance Service Ilsan Hospital Goyang-si Gyeonggi-do
Yongin Severance Hospital, Yonsei University Yongin-si Gyeonggi-do
Kyungpook National University College Hospital Daegu Gyeongsangnam-do
Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do
Jeonbuk National University Hospital Jeonju Jeollabuk-do
Korea University ANAM Hospital Seoul Seoul

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Other trials for the same condition

Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05656118 on ClinicalTrials.gov ↗ ← All trials in South Korea