Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Randomized Clinical Comparison of the Combined 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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Combination Product: PCI with BioMatrix Alpha™ stent
* Combination Product: PCI with Combo™ stent


Participation Criteria
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Eligibility Criteria
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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: Age < 18 years 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combo<br>PCI with COMBO stent | Combination Product: PCI with Combo™ stent<br>* Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent<br>* Other names: Combined sirolimus eluting and endothelial progenitor cell Combo™ stent;|
| Active Comparator: BioMatrix Alpha<br>PCI with BioMatrix Alpha stent | Combination Product: PCI with BioMatrix Alpha™ stent<br>* Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent<br>* Other names: Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stent, Stent