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

Recruiting

• Conditions: In-stent Restenosis; Coronary Artery Disease
• Interventions: Device: Genoss® DCB

• Registration Number: NCT06104007
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2023-08-17
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Target lesion failure	1 year	A composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac event	1 year	A composite of cardiac death, myocardial infarction, and revascularization
Myocardial infarction	1 year	Myocardial infarction
Stroke	1 ye	Stroke
Target vessel myocardial infarction	1 year	Target vessel myocardial infarction
Revascularization	1 year	Revascularization
Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year)	1 year	Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year)
All-cause death	1 year	All-cause death
Major bleeding (BARC type 3, 5)	1 year	Major bleeding (BARC type 3, 5)
Cardiac death	1 year	Cardiac death
Ischemic driven target lesion revascularization	1 year	Ischemic driven target lesion revascularization

Trial Locations

Locations (1)

Bon-Kwon Koo; 🇰🇷 Seoul, Korea, Republic of