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NCT05656118

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

Sponsor: Yonsei University

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of Paclitax Drug Coated Balloon Catheter (Genoss® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study (GENISPIRE Registry)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

260

Start Date

2022-08-31

Completion Date

2028-12-31

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

DEVICE

Genoss® DCB

Paclitaxel coated balloon with a shellac plus vitamin E excipient

Locations (10)

Kosin University Gospel Hospital

Busan, Busan, South Korea

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Yongin Severance Hospital, Yonsei University

Yongin-si, Gyeonggi-do, South Korea

Kyungpook National University College Hospital

Daegu, Gyeongsangnam-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Korea University ANAM Hospital

Seoul, Seoul, South Korea