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Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants. The primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Age 19 and above.

• Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.

• Patients who have undergone percutaneous coronary intervention for stenosis within 5mm of the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case of simultaneous stent placement for other lesions, only GenossTM drug-eluting stents should be used.)

Locations
Other Locations
Republic of Korea
Ajou University Hospital
RECRUITING
Suwon
Contact Information
Primary
seong-jae TaK, MD, PhD
stjahk@gmail.com
820312195712
Backup
Nayeong Lee, RN
yellowfox240@gmail.com
820312195111
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1000
Treatments
OSFITTM drug-eluting stents.
Treatment Group: Group of patients who received treatment with OSFITTM drug-eluting stents.~Subgroup with OCT (OCT Subgroup): Subgroup of patients who underwent Optical Coherence Tomography (OCT) to verify stent placement accuracy.
Related Therapeutic Areas
Sponsors
Leads: Genoss Co., Ltd.

This content was sourced from clinicaltrials.gov