- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01956448
SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® (SO VI)
Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aalborg, Denmark, 9000
- Aalborg University Hospital
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Odense, Denmark, 5000
- Odense University Hospital
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Aarhus N
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Skejby, Aarhus N, Denmark, 8200
- Aarhus University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Drug eluting stent (BioMatrix Flex)
Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)
|
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Other Names:
|
EXPERIMENTAL: Drug eluting stent (Resolute Integrity)
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
|
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device-related combined endpoint
Time Frame: 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. |
1,2,3 and 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause death
Time Frame: 10 years
|
10 years
|
Device success rate
Time Frame: 12 months
|
12 months
|
Procedure success rate
Time Frame: 12 months
|
12 months
|
Procedure time
Time Frame: 12 months
|
12 months
|
Fluoroscopy time
Time Frame: 12 months
|
12 months
|
Amount of contrast
Time Frame: 12 months
|
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
Time Frame: 30 days
|
30 days
|
Target lesion revascularisation
Time Frame: 1,2,3 and 5 years
|
1,2,3 and 5 years
|
Death and myocardial infarction
Time Frame: 1 and 12 months
|
1 and 12 months
|
Stent thrombosis
Time Frame: 1,2,3 and 5 years
|
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
Time Frame: 2,3 and 5 years
|
2,3 and 5 years
|
Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations
Time Frame: 1,2,3 and 5 years
|
1,2,3 and 5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jan Ravkilde, MD, Aalborg University Hospital
Publications and helpful links
General Publications
- 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. Erratum In: Lancet. 2015 Apr 18;385(9977):1510.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20110037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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