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

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

August 17, 2023

Primary Completion Date

June 30, 2028

Study Completion Date

December 31, 2028

Conditions
Coronary Artery DiseaseIn-stent Restenosis
Interventions
DEVICE

Genoss® DCB

This study includes patients with coronary in-stent restenosis (ISR) who have undergone percutaneous coronary intervention (PCI) according to standard treatment protocols using the Genoss® DCB and have agreed to participate in the clinical research. The decision on which drug-coated balloon (DCB) to use during PCI is entirely based on the patient's condition and the characteristics of the coronary lesions identified through angiography. Thus, it's not possible to determine in advance to use the Genoss® DCB before the procedure, nor can the number of drug-coated balloon catheters to be used during the procedure be known or decided upon beforehand.

Trial Locations (1)

Unknown

RECRUITING

Bon-Kwon Koo, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER