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)
NCT Number: NCT06692140
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Aalborg University Hospital, Aalborg, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
Time frame: 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
Time frame: 1 year, 3 years and 5 years
All-cause death is defined as any death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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,
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Odense University Hospital
Other
Randomized Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention in an All Comer Population (The SORT OUT XII Trial)
Acronym: SORT OUT XII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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