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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ACTIVE_NOT_RECRUITING
NA
3148 participants
INTERVENTIONAL
2017-06-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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COMBO
PCI with COMBO stent
COMBO
PCI with COMBO stent
ORSIRO
PCI with ORSIRO stent
ORSIRO
PCI with ORSIRO stent
Interventions
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COMBO
PCI with COMBO stent
ORSIRO
PCI with ORSIRO stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patients will be treated in accordance with the criteria applicable at the individual sites.
* The investigators plan to include 3,140 patients.
Exclusion Criteria
* The patient does not wish to participate
* The patient is not able to consent to randomization (eg intubated patients)
* The patient do not speak Danish
* The patient is already included in this study
* The patient is already participating in other stent studies
* Life expectancy \<1 year
* Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
* Allergic to sirolimus
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
OrbusNeich
INDUSTRY
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Lars Jakobsen
MD
Principal Investigators
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Lars Jakobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital Skejby
Locations
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Aalborg University Hospital, Department of Cardiology
Aalborg, , Denmark
Aarhus University Hospital, Skejby
Aarhus N, , Denmark
Rigshospitalet, Hjertecentret
Copenhagen, , Denmark
Odense Unversity Hospital, Department of Cardiology
Odense C, , Denmark
Countries
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References
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Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Christensen MK, Terkelsen CJ, Aaroe J, Thim T, Lassen JF, Hougaard M, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. EuroIntervention. 2023 Oct 23;19(8):676-683. doi: 10.4244/EIJ-D-23-00330.
Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Ahlehoff O, Christensen MK, Terkelsen CJ, Erik Botker H, Aaroe J, Thim T, Thuesen L, Aziz A, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the Sirolimus-Eluting Orsiro Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT X Trial. Circulation. 2021 Jun;143(22):2155-2165. doi: 10.1161/CIRCULATIONAHA.120.052766. Epub 2021 Apr 7.
Jakobsen L, Christiansen EH, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Madsen M, Raungaard B, Jensen SE, Christensen MK, Hansen HS, Jensen LO. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X trial. Am Heart J. 2018 Aug;202:49-53. doi: 10.1016/j.ahj.2018.04.019. Epub 2018 May 5.
Other Identifiers
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1-10-72-38-17
Identifier Type: -
Identifier Source: org_study_id