Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent (SORT OUT VII)
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 stent in a population-based setting, using registry detection of clinically driven events
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Comparison of a Sirolimus Eluting ORSIRO Stent With a Biolimus-eluting NOBORI Stent in Patients Treated With Percutaneous Coronary Intervention|
- Cardiac death, myocardial infarction or target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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)
- Cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization, all cause mortality, stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Cardiac mortality Myocardial infarction Target lesion revascularization Target vessel revascularization All cause mortality Stent thrombosis rate according to the Academic Research Consortium definition Secondary endpoints will be assessed after 1 year, 2 years, 3 years, 4 years and 5 years.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: ORSIRO stent
ORSIRO stent group
Device: Drug-eluting stent
Active Comparator: NOBORI stent
NOBORI stent group
Device: Drug-eluting stent
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.
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).
Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).
Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death
at least 18 years old chronic stable coronary artery disease or acute coronary syndromes at least one coronary artery lesion with more than 50% diameter stenosis requiring treatment with a drug-eluting stent
life expectancy of less than one year allergy to aspirin, clopidogrel, sirolimus, or biolimus participation in another randomized trial nability to provide written informed consent
|Contact: Lisette Okkels Jensen, MD DMSci PhDfirstname.lastname@example.org|
|Contact: Per Thayssen, MD DMSciemail@example.com|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Lisette Okkels Jensen, MD DMSci PhD 004565412620 firstname.lastname@example.org|
|Contact: Per Thayssen, MD DMSci 004565412691 email@example.com|
|Principal Investigator: Lisette Okkels Jensen, MD DMSci PhD|
|Study Chair:||Jens F Lassen, MD DMSci||Aarhus University Hospital|