Coronary Artery Disease
Conditions
Keywords
Drug eluting stent, Stent
Brief summary
SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.
Detailed description
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
Interventions
COMBINATION_PRODUCTPCI with BioMatrix Alpha™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
COMBINATION_PRODUCTPCI with Combo™ stent
Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
Sponsors
Aarhus University Hospital
Odense University Hospital
OrbusNeich
Biosensors International
Phillip Freeman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization | Within 12 months | 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. |
| Target Lesion Revascularisation (TLR) | Within 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Myocardial Infarction | Through 5 years | 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. |
| Target Lesion Revascularization due to clincal symptoms | Through 5 years | 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. |
| Number of patients with all cause mortality | Through 5 years | Cardiac and non-cardiac |
| Individual components of the primary end point comprise the secondary end points | Clinical follow-up will be continued through 5 years | 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. |
| Number of patients with stent thrombosis | Through 5 years | Definite, probable, possible and overall according to the Academic Research Consortium definition (22) |
| Number of patients with Patient-related composite end point | Through 5 years | All death, all MI (including procedure related MI) or any revascularisation |
| Target Vessel Revascularization due to clincal symptoms | Through 5 years | 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. |
| Number of participants with Cardiac Death | Through 5 years | — |
Countries
Denmark
Outcome results
None listed