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NCT Number: NCT06692140

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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))

Primary outcomes

  1. Number of patients with target lesion failure

    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

Secondary outcomes

  1. Number of patients with all-cause death

    Time frame: 1 year, 3 years and 5 years

    All-cause death is defined as any death

  2. Number of patients with cardiac 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

  3. Number of patients with myocardial infarction

    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

  4. Number of patients with definite stent thrombosis

    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

  5. Number of patients with probable 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,

  6. Number of patients with target lesion revascularization

    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

  7. Number of patients with target vessel revascularization

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisette O Jensen, MD

CONTACT

[email protected]

+4565412690

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Nov 18, 2024
Registry last updated
Dec 9, 2024

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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