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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
| OrbusNeich | INDUSTRY |
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The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.
Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO stent in Patients Treated with Percutaneous Coronary Intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMBO | Experimental | PCI with COMBO stent |
|
| ORSIRO | Active Comparator | PCI with ORSIRO stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMBO | Device | PCI with COMBO 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 | Analysing 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 OsiroTM 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Jakobsen, MD | Aarhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital, Department of Cardiology | Aalborg | 9100 | Denmark | |||
| Aarhus University Hospital, Skejby |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37584207 | Derived | 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. | |
| 33823606 |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D000787 | Angina Pectoris |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ORSIRO | Device | PCI with ORSIRO stent |
|
|
| Clinical follow-up will be continued through 5 years |
| Cardiac death | Through 5 years |
| MI | 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 |
| Clinically indicated TLR | 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 |
| All death | Cardiac and noncardiac | Through 5 years |
| TVR | 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 |
| Stent thrombosis | Definite, probable, possible and overall according to the Academic Research Consortium definition (22) | Through 5 years |
| Patient-related composite end point | All death, all MI (including procedure related MI) or any revascularisation | Through 5 years |
| Aarhus N |
| 8200 |
| Denmark |
| Rigshospitalet, Hjertecentret | Copenhagen | 2100 | Denmark |
| Odense Unversity Hospital, Department of Cardiology | Odense C | 5000 | Denmark |
| Derived |
| 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. |
| 29807307 | Derived | 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. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |