Status:
UNKNOWN
Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent
Lead Sponsor:
Odense University Hospital
Conditions:
Coronary Artery Disease
Ischemic Heart Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the biolimus-eluting NOBORI st...
Detailed Description
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 coron...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
2314 Patients enrolled
Trial Details
Trial ID
NCT01879358
Start Date
November 1 2012
End Date
February 1 2021
Last Update
September 18 2020
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000