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

NCT ID: NCT06104007

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2028-12-31

Brief 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).

Detailed Description

Drug-coated balloon (DCB) treatment is a therapeutic strategy to overcome in-stent restenosis (ISR) that occurs after drug-eluting stent (DES) implantation. The 2018 European guidelines on myocardial revascularization recommend DCB treatment in patients with bare-metal stent (BMS) or DES ISR lesions. The Sequent Please World Wide Registry has shown that DCB therapy is safe and exhibits a low target lesion revascularization (TLR) rate in a large population.

The Genoss® DCB is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. Additionally, it incorporates vitamin E, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. The catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. In a clinical trial comparing Genoss® DCB to the Sequent® Please (B-BRAUN) DCB, the in-segment late lumen loss at six months after DCB was comparable, and the rates of adverse clinical events were similar.

Given this background, this study intends to investigate the long-term efficacy and safety of the Genoss® DCB in patients with coronary ISR.

Conditions

Coronary Artery Disease; In-stent Restenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Genoss® DCB

Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB

Genoss® DCB

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Women of childbearing age who plan to become pregnant during the study duration.
• Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
• Patients for whom the expected remaining life span is less than one year.
• Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
• Patients currently involved in a randomized medical device study.
• Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bon-Kwon Koo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bon-Kwon Koo

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Bon-Kwon Koo, MD, PhD

Role: CONTACT

bkkoo@snu.ac.kr

+82-2-2072-2062

Facility Contacts

Bon-Kwon Koo, MD, PhD

Role: primary

bkkoo@snu.ac.kr

+82-2-2072-2062

Other Identifiers

2304-037-1420

Identifier Type: -

Identifier Source: org_study_id