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

NCT06692140 · tracked via the Priya Life Science Denmark tracker

Sponsor

Odense University Hospital

Phase

Not applicable

Started

2024-11-16

Last updated

2024-12-09

Condition(s) studied

Ischemia, MyocardialCoronary Artery DiseasePercutaneous Coronary Intervention (PCI)

Investigational drug(s) / intervention(s)

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))

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)

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))

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of patients with target lesion failure — 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

Trial sites (3)

Facility	City	Region	Status
Aalborg University Hospital	Aalborg	Denmark	Recruiting
Aarhus University Hospital	Aarhus	Denmark	Recruiting
Odense University Hospital	Odense	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06692140 on ClinicalTrials.gov ↗ ← All trials in Denmark