BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

Odense University Hospital3,150 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,150

Conditions

Ischaemic Heart Disease

Interventions

BiofreedomDEVICE

PCI with Biofreedom stent

OrsiroDEVICE

PCI with Orsiro stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Target Lesion Failure

Primary endpoint assessed after 12 months

Time frame: 12 months

Secondary Outcomes

Target lesion failure

Target lesion failure will be assessed yearly up to 5 years after index procedure

Time frame: 2 year, 3 year, 4 year, 5 year

Stent thrombosis

Stent thrombosis will be assessed yearly up to 5 years after index procedure