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)

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)

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Ischemia, Myocardial; Percutaneous Coronary Intervention (PCI)
• Intervention / Treatment: 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
• Enrollment (Estimated): 3150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisette O Jensen, MD; Phone Number: +4565412690; Email: lisette.okkels.jensen@rsyd.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Ashkan Eftekhari, MD; Phone Number: +4597660000; Email: asef@rn.dk
    • Contact: Ashkan Eftekhari, MD
    • Contact: Phillip Freeman, MD
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Evald H Christiansen, MD; Phone Number: +4578450000; Email: evald.christiansen@rm.dk
    • Contact: Evald H Christiansen, MD
    • Contact: Lars Jakobsen, MD
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Lisette O Jensen, MD; Phone Number: +4565412620; Email: lisette.okkels.jensen@rsyd.dk
    • Contact: Lisette O Jensen, MD
    • Contact: Jens F Lassen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent; 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); Percutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
Active Comparator: Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent); 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)); Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with all-cause death	All-cause death is defined as any death	1 year, 3 years and 5 years
Number of patients with cardiac death	Cardiac death is defined as death resulting from cardiovascular causes: death caused by acute myocardial infarction, death caused by sudden cardiac, including unwitnessed, death, death resulting from heart failure, death caused by cardiovascular procedures. Undetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents. Such deaths will be classified as cardiovascular for end point determination	1 year, 3 years and 5 years
Number of patients with myocardial infarction	Myocardial infarction diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of acute myocardial infarction",which has been adapted by Academy Research Consortium. Acute myocardial infarction not related to other than index lesion is defined as any acute myocardial infarction that is not clearly attributable to a non-target vessel	1 year, 3 years and 5 years
Number of patients with definite stent thrombosis	Definite stent thrombosis is defined as: Angiographic confirmation of stent thrombosis. The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent or in a side branch originating from the stented segment and the presence of at least one of the following criteria: Acute onset of ischemic symptoms at rest New electrocardiographic changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) Or Pathological confirmation of stent thrombosis	1 year, 3 years and 5 years
Number of patients with probable stent thrombosis	Probable stent thrombosis is defined as any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause regardless of the time after the index procedure,	1 year, 3 years and 5 years
Number of patients with target lesion revascularization	Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment including the 5-mm margin proximal and distal to the stent	1 year, 3 years and 5 years
Number of patients with target vessel revascularization	Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. The target vessel is defined as the entire major intervened coronary vessel, including side branches	1 year, 3 years and 5 years

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Lisette O Jensen, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: outcome; Drug-eluting stent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; MTOR Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Everolimus
• Other Study ID Numbers: SORT OUT XII STENT; VMK2401000 (Other Identifier: Odense University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD used in the results publication
• IPD Sharing Time Frame: 12. NOV 2024 til the end of the study
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No