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Completed
NCT02623140
BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX
Conditions: Ischaemic Heart Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 3150
Sponsor: Odense University Hospital
Location: Odense University Hospital Odense
Summary
The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events
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.
Exclusion Criteria:
* Life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.
Source: ClinicalTrials.gov (NCT02623140). StuddyBuddy aggregates publicly available trial information.