Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent

Study Overview
=================
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 stent in a population-based setting, using registry detection of clinically driven events

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 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 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 Inclusion criteria: 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 Exclusion criteria: 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

Official Title
-----------------
Randomized Comparison of a Sirolimus Eluting ORSIRO Stent With a Biolimus-eluting NOBORI Stent in Patients Treated With Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
-----------------
* Device: Drug-eluting stent


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ORSIRO stent<br>ORSIRO stent group | Device: Drug-eluting stent<br> <br> * Other names: NOBORI biolimus-eluting stent;|
| Active Comparator: NOBORI stent<br>NOBORI stent group | Device: Drug-eluting stent<br> <br> * Other names: NOBORI biolimus-eluting stent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death, myocardial infarction or target lesion revascularization | 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization, all cause mortality, stent thrombosis | 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-eluting stent, Safety, Efficacy