Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
Sponsor: Yonsei University
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
Conditions
Interventions
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