Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De No… (NCT07158307) | Clinical Trial Compass
By InvitationNot Applicable
Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion
South Korea3,000 participantsStarted 2024-06-27
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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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