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RECRUITING
NCT06104007

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2023-08-17

Completion Date

2028-12-31

Last Updated

2023-10-27

Healthy Volunteers

No

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.

Locations (1)

Bon-Kwon Koo

Seoul, South Korea