Angina Pectoris, Coronary Artery Disease
Conditions
Keywords
Percutaneous coronary intervention, DES, Angina pectoris, Stent
Brief summary
To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.
Detailed description
SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions. Primary Endpoint: Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization). Secondary Endpoints: Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints). Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death
Interventions
DEVICEDrug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Sponsors
Biosensors International
Medtronic Cardiovascular
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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, prasugrel, sirolimus, or biolimus * participation in another randomized trial * inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-related combined endpoint | 1,2,3 and 5 years | Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success rate | 12 months |
| Procedure time | 12 months |
| Fluoroscopy time | 12 months |
| Amount of contrast | 12 months |
| Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation | 30 days |
| Device success rate | 12 months |
| Death and myocardial infarction | 1 and 12 months |
| Stent thrombosis | 1,2,3 and 5 years |
| Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion | 2,3 and 5 years |
| Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations | 1,2,3 and 5 years |
| All-cause death | 10 years |
| Target lesion revascularisation | 1,2,3 and 5 years |
Countries
Denmark
Outcome results
None listed