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 (SORT OUT XII)

Odense University Hospital

Status: Enrolling

Conditions: Coronary Artery Disease; Ischemia, Myocardial; Percutaneous Coronary Intervention (PCI)

Treatments: Device: 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))

Study type: Interventional

Funder types: Other

Identifiers

NCT06692140

SORT OUT XII STENT

VMK2401000 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 3,150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,150 participants in 2 patient groups

Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent

Experimental group

Description:

Percutaneous coronary interventin with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent

Treatment:

Device: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)

Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)

Active Comparator group

Description:

Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)

Treatment:

Device: PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))