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| ID | Type | Description | Link |
|---|---|---|---|
| VMK2401000 | Other Identifier | Odense University Hospital |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent | Experimental | Percutaneous coronary interventin with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent |
|
| Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent) | Active Comparator | Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s) | Device | Percutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with all-cause death | All-cause death is defined as any death | 1 year, 3 years and 5 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisette O Jensen, MD | Contact | +4565412690 | lisette.okkels.jensen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lisette O Jensen | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
IPD used in the results publication
12. NOV 2024 til the end of the study
On request
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| PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s)) | Device | Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s)) |
|
| 1 year, 3 years and 5 years |
| 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 | 1 year, 3 years and 5 years |
| 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 | 1 year, 3 years and 5 years |
| Number of patients with probable stent thrombosis | 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, | 1 year, 3 years and 5 years |
| Number of patients with target lesion revascularization | 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 | 1 year, 3 years and 5 years |
| Number of patients with target vessel revascularization | 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 | 1 year, 3 years and 5 years |
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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