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

Coronary Artery Disease Clinical Trial

— SFRGENISTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104007
• Other study ID #: 2304-037-1420
• Status: Recruiting
• Start date: August 17, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: +82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• In-stent Restenosis
• Myocardial Ischemia

Intervention

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

Country	Name	City	State
Korea, Republic of	Bon-Kwon Koo	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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