SORT OUT X - Combo Stent Versus ORSIRO Stent

Myocardial Infarction Clinical Trial

— SORT OUT X  

Official title:

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 - The SORT-OUT X Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03216733
• Other study ID #: 1-10-72-38-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3148
• Est. completion date: December 31, 2028
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• COMBO
PCI with COMBO stent
• ORSIRO
PCI with ORSIRO stent

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Department of Cardiology	Aalborg
Denmark	Aarhus University Hospital, Skejby	Aarhus N
Denmark	Rigshospitalet, Hjertecentret	København
Denmark	Odense Unversity Hospital, Department of Cardiology	Odense C

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Biotronik SE & Co. KG, OrbusNeich

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization	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	Within 12 months
Primary	Target Lesion Revascularisation (TLR)	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.	Within 12 months
Secondary	Individual components of the primary end point comprise the secondary end points	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.	Clinical follow-up will be continued through 5 years
Secondary	Cardiac death		Through 5 years
Secondary	MI	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.	Through 5 years
Secondary	Clinically indicated TLR	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.	Through 5 years
Secondary	All death	Cardiac and noncardiac	Through 5 years
Secondary	TVR	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.	Through 5 years
Secondary	Stent thrombosis	Definite, probable, possible and overall according to the Academic Research Consortium definition (22)	Through 5 years
Secondary	Patient-related composite end point	All death, all MI (including procedure related MI) or any revascularisation	Through 5 years