Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent
Launched by ODENSE UNIVERSITY HOSPITAL · Jun 14, 2013
Trial Information
Current as of May 21, 2025
Unknown status
Keywords
ClinConnect Summary
SORT OUT VII is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the sirolimus eluting ORSIRO stent to the biolimus-eluting NOBORI stent in treating atherosclerotic coronary artery lesions.
Primary Endpoint:
Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).
Secondary Endpoints:
Individual components of the primary end point comprised the secondary end points and stent thrombosis rate accord...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. There are no restrictions on number of treated lesions, number of treated vessels, or lesion length.
- Exclusion Criteria:
- • Exclusion criteria are life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, sirolimus, or biolimus; participation in another randomized trial; or inability to provide written informed consent
About Odense University Hospital
Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Odense, , Denmark
Patients applied
Trial Officials
Jens F Lassen, MD DMSci
Study Chair
Aarhus University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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