BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

Study Overview
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Brief Summary
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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

Detailed Description
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SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions. Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.

Official Title
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Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention

Conditions
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Ischaemic Heart Disease

Intervention / Treatment
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* Device: Biofreedom
* Device: Orsiro


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, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofreedom<br>Biofreedom stent treatment at index procedure | Device: Biofreedom<br>* PCI with Biofreedom stent<br>|
| Active Comparator: Orsiro<br>Orsiro stent treatment at index procedure | Device: Orsiro<br>* PCI with Orsiro stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure | Primary endpoint assessed after 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Target lesion failure will be assessed yearly up to 5 years after index procedure | 2 year, 3 year, 4 year, 5 year | 
| Stent thrombosis | Stent thrombosis will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Myocardial infarction | Myocardial infarction will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Cardiac death | Cardiac death will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years | 
| All cause mortality | All cause mortality will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Target lesion revascularization | Target lesion revascularization will be assessed yearly up to 5 years after index procedure | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Target vessel revascularization | Target vessel revascularization will be assessed yearly up to 5 years after | 1 year, 2 years, 3 years, 4 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary drug eluting stents, Outcomes