Comparison Between Abluminal Biodegradable Polymer Ultrathin Sirolimus-eluting Stent and Durable-polymer Everolimus-eluting Stent (GENOSS Randomized Clinical Trial)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to evaluate the efficacy and safety of abluminal biodegradable polymer ultrathin sirolimus-eluting stent (Genoss stent) as compared with a durable-polymer everolimus-eluting stent (Xience stent) in patients with coronary artery disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• ① Subject must be at least 19 years of age
• ② Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
• ③ Patients with stable coronary artery disease or acute coronary syndrome and at least one lesion with greater than 50% diameter stenosis suitable for stent implantation
Locations
Other Locations
Republic of Korea
Cardiac and Vascular Center; Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Hyeon-Cheol Gwon, MD, PhD
hcgwon@naver.com
82-2-3410-3694
Time Frame
Start Date: 2022-04-24
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 850
Treatments
Experimental: GENOSS stent arm
Coronary lesions of the subjects this arm will be treated with GENOSS stent when in need of stent implantation
Active_comparator: XIENCE stent arm
Coronary lesions of the subjects this arm will be treated with Xience stent when in need of stent implantation
Related Therapeutic Areas
Sponsors
Collaborators: Genoss Company Limited, Suwon, Korea
Leads: Samsung Medical Center