BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

Ischaemic Heart Disease Clinical Trial

— SORT OUT IX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02623140
• Other study ID #: SORT OUT IX
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: October 2023

Study information

• Verified date: September 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3150
• Est. completion date: October 2023
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischaemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Biofreedom
PCI with Biofreedom stent
• Orsiro
PCI with Orsiro stent

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Aalborg University Hospital, Aarhus University Hospital Skejby, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure	Primary endpoint assessed after 12 months	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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