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Recruiting 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

No phase Interventional Ischemia, Myocardial Coronary Artery Disease Percutaneous Coronary Intervention (PCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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)).
Who it may be relevant to
Registry conditions: Ischemia, Myocardial, Coronary Artery Disease, Percutaneous Coronary Intervention (PCI). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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

Interventions

  • Device Ultra-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)
  • Device PCI 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))

Primary outcome measures

  • Number of patients with target lesion failure [Time frame: 1 year]
Secondary outcome measures (7)
  • Number of patients with all-cause death [Time frame: 1 year, 3 years and 5 years]
  • Number of patients with cardiac death [Time frame: 1 year, 3 years and 5 years]
  • Number of patients with myocardial infarction [Time frame: 1 year, 3 years and 5 years]
  • Number of patients with definite stent thrombosis [Time frame: 1 year, 3 years and 5 years]
  • Number of patients with probable stent thrombosis [Time frame: 1 year, 3 years and 5 years]
  • Number of patients with target lesion revascularization [Time frame: 1 year, 3 years and 5 years]
  • Number of patients with target vessel revascularization [Time frame: 1 year, 3 years and 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 3 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • Odense University Hospital — Odense

Identifiers

NCT: NCT06692140 · SORT OUT XII STENT · VMK2401000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗