Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion (PCB-De Novo)

Genoss

Status: Invitation-only

Conditions: Coronary Artery Disease(CAD)

Study type: Observational

Funder types: Industry

Identifiers

NCT07158307

CIP-DS1001-3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

GENOSS® DCB (Paclitaxel-coated PTCA Balloon Catheter)

Description:

Patients with de novo small coronary artery disease who underwent PCI with GENOSS DCB