SORT OUT X - Combo Stent Versus ORSIRO Stent

Not Applicable

Active, not recruiting

• Conditions: Angina Pectoris; Myocardial Infarction; Coronary Heart Disease
• Interventions: Device: ORSIRO; Device: COMBO

• Registration Number: NCT03216733
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of unselected patients with ischemic heart disease, using registry detection of clinically driven events.

Detailed Description

Randomized Clinical Comparison of a Combined Sirolimus Eluting and endothelial progenitor cell COMBO Stent with a Sirolimus-eluting OSIRO stent in Patients Treated with Percutaneous Coronary Intervention.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Primary Completion: 2018-11-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-25
• Last Update Posted: 2023-11-28
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3148

Inclusion Criteria

• All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at Rigshospitalet or one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.
• The patients will be treated in accordance with the criteria applicable at the individual sites.
• The investigators plan to include 3,140 patients.

Exclusion Criteria

• Age < 18 years
• The patient does not wish to participate
• The patient is not able to consent to randomization (eg intubated patients)
• The patient do not speak Danish
• The patient is already included in this study
• The patient is already participating in other stent studies
• Life expectancy <1 year
• Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
• Allergic to sirolimus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORSIRO	ORSIRO	PCI with ORSIRO stent
COMBO	COMBO	PCI with COMBO stent

Primary Outcome Measures

Name	Time	Method
Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization	Within 12 months	Analysing the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval.; Patients treated with the OsiroTM stent will be used as the reference group
Target Lesion Revascularisation (TLR)	Within 12 months	Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90). TLR will be clinically driven.

Secondary Outcome Measures

Name	Time	Method
Cardiac death	Through 5 years
All death	Through 5 years	Cardiac and noncardiac
Individual components of the primary end point comprise the secondary end points	Clinical follow-up will be continued through 5 years	cardiac death; MI; clinically indicated TLR; all death (cardiac and noncardiac) and target vessel revascularisation (TVR); definite, probable, possible, and overall stent thrombosis according to the Academic Research Consortium definition (22); and a patient-related composite end point (all death, all MI (including procedure related MI), or any revascularization). For continuous variables, the difference between the treatment groups will be evaluated using Wilcoxon's rank-sum test. For discrete variables, the differences will be given as numbers and in percentages and will be analyzed using Fisher's exact test. Two-sided test will be used, and a pvalue of 0.05 considered significant.
Stent thrombosis	Through 5 years	Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
Clinically indicated TLR	Through 5 years	Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90.
TVR	Through 5 years	Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90.
MI	Through 5 years	The acute MI diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of MI" (23), which has been adapted by Academy Research Consortium (22).; In cases of updates of the definition of MI, the latest definition will be used.
Patient-related composite end point	Through 5 years	All death, all MI (including procedure related MI) or any revascularisation

Trial Locations

Locations (4)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark

Rigshospitalet, Hjertecentret; 🇩🇰 København, Denmark

Odense Unversity Hospital, Department of Cardiology; 🇩🇰 Odense C, Denmark

Aalborg University Hospital, Department of Cardiology; 🇩🇰 Aalborg, Denmark