Coronary Artery Disease, Ischemia, Myocardial, Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Drug-eluting stent, outcome
Brief summary
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
Interventions
DEVICEUltra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
Percutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
DEVICEPCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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
Exclusion criteria
* 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 * Already included in the SORT OUT XII study * Life expectancy \<1 year * Allergic to study related treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with target lesion failure | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with cardiac death | 1 year, 3 years and 5 years | 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 | 1 year, 3 years and 5 years | 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 | 1 year, 3 years and 5 years | 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 |
| Number of patients with all-cause death | 1 year, 3 years and 5 years | All-cause death is defined as any death |
| Number of patients with target lesion revascularization | 1 year, 3 years and 5 years | Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment including the 5-mm margin proximal and distal to the stent |
| Number of patients with target vessel revascularization | 1 year, 3 years and 5 years | Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. The target vessel is defined as the entire major intervened coronary vessel, including side branches |
| Number of patients with probable stent thrombosis | 1 year, 3 years and 5 years | Probable stent thrombosis is defined as any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause regardless of the time after the index procedure, |
Countries
Denmark
Contacts
Primary ContactLisette O Jensen, MD
Outcome results
None listed