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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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))

Treatment groups

3,150 Participants
are divided into 2 treatment groups
Group A: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stentExperimental treatment 1 intervention
Group B: Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

1

Number of patients with all-cause death

All-cause death is defined as any death

Time frame
1 year, 3 years and 5 years
2

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

Time frame
1 year, 3 years and 5 years
3

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

Time frame
1 year, 3 years and 5 years
4

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

Time frame
1 year, 3 years and 5 years

Other outcomes

Sponsors and contacts

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