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
3141 participants
INTERVENTIONAL
2019-08-14
2030-11-30
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
PCI with Combo™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
BioMatrix Alpha
PCI with BioMatrix Alpha stent
PCI with BioMatrix Alpha™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Interventions
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PCI with BioMatrix Alpha™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
PCI with Combo™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 the SORT OUT XI study
* Life expectancy \<1 year
* Allergic to study related treatment
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
OrbusNeich
INDUSTRY
Biosensors International
OTHER
Phillip Freeman
OTHER
Responsible Party
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Phillip Freeman
Principal Investigator, MD
Principal Investigators
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Phillip Freemann, MD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Locations
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Aarhus University Hospital, Skejby
Aarhus, , Denmark
Odense Unversity Hospital
Odense, , Denmark
Countries
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References
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Eftekhari A, Jensen LO, Veien K, Raungaard B, Rasmussen JG, Maeng M, Terkelsen CJ, Ellert-Gregersen J, Stottrup NB, Lassen JF, Hansen HS, Thim T, Jensen RV, Nielsen R, Jensen SE, Kristensen SD, Hougaard M, Junker A, Christensen MK, Aaroe J, Froslev T, Jakobsen L, Christiansen EH. Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial. J Am Coll Cardiol. 2025 Jul 15;86(2):106-115. doi: 10.1016/j.jacc.2025.05.012. Epub 2025 May 21.
Eftekhari A, Christiansen EH, Lassen JF, Raungaard B, Jakobsen L, Jensen LO. Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial. Am Heart J. 2025 May;283:37-42. doi: 10.1016/j.ahj.2025.01.012. Epub 2025 Jan 25.
Other Identifiers
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Sort Out XI
Identifier Type: -
Identifier Source: org_study_id
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