Menu
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

— Observational Coronary Artery Disease In-stent Restenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genoss® DCB.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, In-stent Restenosis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Target lesion failure [Time frame: 1 year]
Secondary outcome measures (10)
  • Major adverse cardiac event [Time frame: 1 year]
  • All-cause death [Time frame: 1 year]
  • Cardiac death [Time frame: 1 year]
  • Myocardial infarction [Time frame: 1 year]
  • Target vessel myocardial infarction [Time frame: 1 year]
  • Revascularization [Time frame: 1 year]
  • Ischemic driven target lesion revascularization [Time frame: 1 year]
  • Major bleeding (BARC type 3, 5) [Time frame: 1 year]
  • Stroke [Time frame: 1 ye]
  • Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year) [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Bon-Kwon Koo — Seoul

Identifiers

NCT: NCT06104007 · 2304-037-1420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗