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 | Recruiting DMC

• 2 other identifiers: SORT OUT XII STENTVMK2401000
• Study Type: interventional
• Target: 3,150
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

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

Keywords

Drug-eluting stent; outcome

Outcome Measures

Primary Outcomes (1)

• Number of patients with target lesion failure

  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

  1 year

Secondary Outcomes (7)

• Number of patients with all-cause death

  1 year, 3 years and 5 years

• Number of patients with cardiac death

  1 year, 3 years and 5 years

• Number of patients with myocardial infarction

  1 year, 3 years and 5 years

• Number of patients with definite stent thrombosis

  1 year, 3 years and 5 years

• Number of patients with probable stent thrombosis

  1 year, 3 years and 5 years

Study Arms (2)

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

EXPERIMENTAL

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

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

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

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

Interventions

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

Percutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Lisette O Jensen

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisette O Jensen, MD

CONTACT

+4565412690; lisette.okkels.jensen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: November 16, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2032
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12\. NOV 2024 til the end of the study
• Access Criteria: On request

Locations

DK (3)