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

NCT05656118 | Active Not Recruiting

• 1 other identifier: 9-2022-0063
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

In-stent Restenosis

Keywords

In-stent Restenosis; Drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• Targeted lesion failure

  A composite of cardiac death, target-vessel MI, or target lesion revascularization

  12 months

Secondary Outcomes (7)

• Major adverse cardiovascular events

  12 months

• All-cause death

  12 months

• Any MI

  12 months

• Any revascularization

  12 months

• Major bleeding events, BARC 3, 5

  12 months

Study Arms (1)

Paclitaxel Coated Balloon

Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR)

Device: Genoss® DCB

Interventions

Genoss® DCB DEVICE

Paclitaxel coated balloon with a shellac plus vitamin E excipient

Paclitaxel Coated Balloon

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (10)

Kosin University Gospel Hospital

Busan, Busan, 49267, South Korea

Location

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Yongin Severance Hospital, Yonsei University

Yongin-si, Gyeonggi-do, 16995, South Korea

Location

Kyungpook National University College Hospital

Daegu, Gyeongsangnam-do, 136-705, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Korea University ANAM Hospital

Seoul, Seoul, 02841, South Korea

Location

Study Officials

• Deok-Kyu Cho, MD

  Yongin Severance Hospital, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 19, 2022
• Study Start: August 31, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)