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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
• Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.
Locations
Other Locations
Republic of Korea
Bon-Kwon Koo
RECRUITING
Seoul
Contact Information
Primary
Bon-Kwon Koo, MD, PhD
bkkoo@snu.ac.kr
+82-2-2072-2062
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1000
Treatments
Genoss® DCB
Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital