Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
In-stent Restenosis
Keywords: Coronary Artery Disease
In-stent Restenosis
Drug-coated Balloon
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary in-stent restenosis who underwent percutaneous coronary intervention using the Genoss® DCB.

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.

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.

Primary outcomes:
measure: Target lesion failure
timeFrame: 1 year
Secondary outcomes:
measure: Major adverse cardiac event
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
measure: Cardiac death
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Target vessel myocardial infarction
timeFrame: 1 year
measure: Revascularization
timeFrame: 1 year
measure: Ischemic driven target lesion revascularization
timeFrame: 1 year
measure: Major bleeding (BARC type 3, 5)
timeFrame: 1 year
measure: Stroke
timeFrame: 1 ye
measure: Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bon-Kwon Koo
Study officials:
References: