About this trial
The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents
Disqualifiers
Age < 18 years
Not able to consent to study participating (eg. intubated patients)
Unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study
Do not speak Danish
Trial design
Parallel
Treatments tested in this trial
Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
DevicePercutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
DevicePercutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with target lesion failure
Target lesion failure (TLF) is a composite of cardiac death, myocardial infarction (not clearly attributable to a non-intervention lesion) or target lesion revascularization with percutaneous coronary intervention or coronary artery bypass operation
Secondary outcomes
Number of patients with all-cause death
All-cause death is defined as any death
Number of patients with cardiac death
Cardiac death is defined as death resulting from cardiovascular causes: death caused by acute myocardial infarction, death caused by sudden cardiac, including unwitnessed, death, death resulting from heart failure, death caused by cardiovascular procedures. Undetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents. Such deaths will be classified as cardiovascular for end point determination
Number of patients with myocardial infarction
Myocardial infarction diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of acute myocardial infarction",which has been adapted by Academy Research Consortium. Acute myocardial infarction not related to other than index lesion is defined as any acute myocardial infarction that is not clearly attributable to a non-target vessel
Number of patients with definite stent thrombosis
Definite stent thrombosis is defined as: Angiographic confirmation of stent thrombosis. The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent or in a side branch originating from the stented segment and the presence of at least one of the following criteria: Acute onset of ischemic symptoms at rest New electrocardiographic changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) Or Pathological confirmation of stent thrombosis
Sponsors and contacts
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