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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Odense University Hospital | OTHER |
| OrbusNeich | INDUSTRY |
| Biosensors International |
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SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.
Randomized clinical comparison of the Sirolimus eluting and endothelial progenitor cell Combo™ stent and the Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent in patients treated with percutaneous coronary intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combo | Active Comparator | PCI with COMBO stent |
|
| BioMatrix Alpha | Active Comparator | PCI with BioMatrix Alpha stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI with BioMatrix Alpha™ stent | Combination Product | Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization | The primary endpoint will be analyzed using the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval. Patients treated with the ComboTM stent will be used as the reference group. | Within 12 months |
| Target Lesion Revascularisation (TLR) | Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90). TLR will be clinically driven. | Within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Individual components of the primary end point comprise the secondary end points | cardiac death; MI; clinically indicated TLR; all death (cardiac and noncardiac) and target vessel revascularisation (TVR); definite, probable, possible, and overall stent thrombosis according to the Academic Research Consortium definition (22); and a patient-related composite end point (all death, all MI (including procedure related MI), or any revascularization). For continuous variables, the difference between the treatment groups will be evaluated using Wilcoxon's rank-sum test. For discrete variables, the differences will be given as numbers and in percentages and will be analyzed using Fisher's exact test. Two-sided test will be used, and a pvalue of 0.05 considered significant. |
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Inclusion Criteria:
All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Freemann, MD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Skejby | Aarhus | 8200 | Denmark | |||
| Odense Unversity Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40406942 | Derived | 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. | |
| 39870125 |
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Only shared with collaborators
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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|
| PCI with Combo™ stent | Combination Product | Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent |
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| Clinical follow-up will be continued through 5 years |
| Number of participants with Cardiac Death | Through 5 years |
| Number of participants with Myocardial Infarction | The acute MI diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of MI" (23), which has been adapted by Academy Research Consortium (22). In cases of updates of the definition of MI, the latest definition will be used. | Through 5 years |
| Target Lesion Revascularization due to clincal symptoms | Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90. | Through 5 years |
| Number of patients with all cause mortality | Cardiac and non-cardiac | Through 5 years |
| Target Vessel Revascularization due to clincal symptoms | Angina, CCS > 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR <0.80, or iFR< 0.90. | Through 5 years |
| Number of patients with stent thrombosis | Definite, probable, possible and overall according to the Academic Research Consortium definition (22) | Through 5 years |
| Number of patients with Patient-related composite end point | All death, all MI (including procedure related MI) or any revascularisation | Through 5 years |
| Odense |
| 5000 |
| Denmark |
| Derived |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |