SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®

Study Overview
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Brief Summary
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To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.

Detailed Description
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SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of 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

Official Title
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Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*

Conditions
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Coronary Artery Disease, Angina Pectoris

Intervention / Treatment
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* Device: Drug eluting stent


Participation Criteria
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Eligibility Criteria
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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, prasugrel, sirolimus, or biolimus participation in another randomized trial inability to provide written informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug eluting stent (BioMatrix Flex)<br>Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex) | Device: Drug eluting stent<br>* Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)<br>* Other names: Resolute - zotarolimus eluting stent;|
| Experimental: Drug eluting stent (Resolute Integrity)<br>Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity) | Device: Drug eluting stent<br>* Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)<br>* Other names: Resolute - zotarolimus eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related combined endpoint | Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months. | 1,2,3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate |  | 12 months | 
| Procedure success rate |  | 12 months | 
| Procedure time |  | 12 months | 
| Fluoroscopy time |  | 12 months | 
| Amount of contrast |  | 12 months | 
| Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation |  | 30 days | 
| Target lesion revascularisation |  | 1,2,3 and 5 years | 
| Death and myocardial infarction |  | 1 and 12 months | 
| Stent thrombosis |  | 1,2,3 and 5 years | 
| Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion |  | 2,3 and 5 years | 
| Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations |  | 1,2,3 and 5 years | 
| All-cause death |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, DES, Angina pectoris, Stent