The GENOSS PCB-De Novo 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 De novo small coronary artery disease.

This prospective, open-label, multicenter, observational study will enroll patients with de novo small coronary artery disease undergoing PCI with the GENOSS® DCB at 47 hospitals.

Because this is an observational study, the number of participants will not be calculated separately, but a total of 3,000 participants are planned to be recruited during the study enrollment period.

All patients will be followed up at 1, 2, and 3 years postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTCA balloon catheter.

Inclusion Criteria:

• Adults over the age of 19
• Patients with new lesions with coronary small vascular disease (vascular diameter <3.0 mm) underwent a GENOSS® DCB procedure through percutaneous coronary intervention
• Subjects who agreed to the clinical research plan and the clinical follow-up plan, voluntarily decided to participate in this clinical study, and agreed in writing to the consent of the study subjects

Exclusion Criteria:

• Subjects who plan to become pregnant during the period of this study as women of the gestational age

• Subjects whose remaining life expectancy is expected to be less than one year

• Subjects who visited the hospital due to psychogenic shock at the time of visiting the hospital and are predicted to have a low chance of survival based on medical judgment

• If it falls under any of the following items after prior dilation of the target lesion;

  • Stent procedures are required due to vascular detachment that limits blood flow
  • If the residual stenosis is >30%
  • If the TIMI flow is <3

• Subjects participating in a randomized study of medical devices

• If the researcher determines that it is not appropriate for this clinical study or may increase the risk associated with participation in the study

Subjects who underwent PCI with GENOSS DCB for small coronary artery disease with de novo lesions