SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®
NCT ID: NCT01956448
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2800 participants
INTERVENTIONAL
2011-03-31
2012-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug eluting stent (BioMatrix Flex)
Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)
Drug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Drug eluting stent (Resolute Integrity)
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Drug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Interventions
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Drug eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
* participation in another randomized trial
* inability to provide written informed consent
ALL
No
Sponsors
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Biosensors International
OTHER
Medtronic Cardiovascular
INDUSTRY
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Evald Hoej Christiansen
MD, DMSc
Principal Investigators
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Jan Ravkilde, MD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Locations
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Aarhus University Hospital
Skejby, Aarhus N, Denmark
Aalborg University Hospital
Aalborg, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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Raungaard B, Christiansen EH, Botker HE, Hansen HS, Ravkilde J, Thuesen L, Aaroe J, Villadsen AB, Terkelsen CJ, Krusell LR, Maeng M, Kristensen SD, Veien KT, Hansen KN, Junker A, Madsen M, Andersen SL, Jensen SE, Jensen LO; SORT OUT VI Investigators. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial. JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264. doi: 10.1016/j.jcin.2016.11.007. Epub 2017 Jan 18.
Raungaard B, Jensen LO, Tilsted HH, Christiansen EH, Maeng M, Terkelsen CJ, Krusell LR, Kaltoft A, Kristensen SD, Botker HE, Thuesen L, Aaroe J, Jensen SE, Villadsen AB, Thayssen P, Veien KT, Hansen KN, Junker A, Madsen M, Ravkilde J, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial. Lancet. 2015 Apr 18;385(9977):1527-35. doi: 10.1016/S0140-6736(14)61794-3. Epub 2015 Jan 16.
Other Identifiers
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M-20110037
Identifier Type: -
Identifier Source: org_study_id