Ischaemic Heart Disease
Conditions
Keywords
Coronary drug eluting stents, Outcomes
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.
Interventions
DEVICEOrsiro
PCI with Orsiro stent
DEVICEBiofreedom
PCI with Biofreedom stent
Sponsors
Aarhus University Hospital Skejby
Aalborg University Hospital
Rigshospitalet, Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure | 12 months | Primary endpoint assessed after 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 vessel revascularization | 1 year, 2 years, 3 years, 4 years, 5 years | Target vessel revascularization will be assessed yearly up to 5 years after |
Countries
Denmark
Outcome results
None listed