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

Last updated: December 4, 2024
Sponsor: Odense University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Vascular Diseases

Thrombosis

Treatment

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))

Clinical Study ID

NCT06692140
SORT OUT XII STENT
VMK2401000
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 theinformation 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

Study Design

Total Participants: 3150
Treatment Group(s): 2
Primary Treatment: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
Phase:
Study Start date:
November 16, 2024
Estimated Completion Date:
July 01, 2032

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

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