BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

Phase 4

• Conditions: Ischaemic Heart Disease
• Interventions: Device: Orsiro; Device: Biofreedom

• Registration Number: NCT02623140
• Lead Sponsor: Odense University Hospital

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 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

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.

Study Timeline

• Study First Submitted: 2015-11-30
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-07
• Primary Completion: 2018-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orsiro	Orsiro	Orsiro stent treatment at index procedure
Biofreedom	Biofreedom	Biofreedom stent treatment at index procedure

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure	12 months	Primary endpoint assessed after 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark