RecruitingNot ApplicableNCT06692140

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

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)


Sponsor

Odense University Hospital

Enrollment

3,150 participants

Start Date

Nov 16, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents

Exclusion Criteria7

  • 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

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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))


Locations(3)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Odense University Hospital

Odense, Denmark

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NCT06692140


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