NCT07158307Enrolling by invitation
Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion
Safety and Efficacy of Paclitaxel-coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With De Novo Lesion of Small Coronary Artery Disease: A Prospective, Multi-center, Observational Study
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 27 Jun 2024
- Primary completion date
- 27 Jun 2030
- Lead sponsor
- Genoss Co., Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT07158307
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 27 Jun 2024 to the primary completion date, 27 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Age
- Subjects who plan to become pregnant during the period of this study as women of the gestational age
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.