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SORT OUT X - Combo Stent Versus ORSIRO Stent (SORT OUT X)

Primary Purpose

Coronary Heart Disease, Angina Pectoris, Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
COMBO
ORSIRO
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring DES, Angina pectoris, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University Hospital, Department of Cardiology
  • Aarhus University Hospital, Skejby
  • Rigshospitalet, Hjertecentret
  • Odense Unversity Hospital, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COMBO

ORSIRO

Arm Description

PCI with COMBO stent

PCI with ORSIRO stent

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
Cardiac death
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.
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.
All death
Cardiac and noncardiac
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.
Stent thrombosis
Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
Patient-related composite end point
All death, all MI (including procedure related MI) or any revascularisation

Full Information

First Posted
July 4, 2017
Last Updated
October 29, 2022
Sponsor
Aarhus University Hospital Skejby
Collaborators
Biotronik SE & Co. KG, OrbusNeich
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1. Study Identification

Unique Protocol Identification Number
NCT03216733
Brief Title
SORT OUT X - Combo Stent Versus ORSIRO Stent
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Biotronik SE & Co. KG, OrbusNeich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Angina Pectoris, Myocardial Infarction
Keywords
DES, Angina pectoris, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COMBO
Arm Type
Experimental
Arm Description
PCI with COMBO stent
Arm Title
ORSIRO
Arm Type
Active Comparator
Arm Description
PCI with ORSIRO stent
Intervention Type
Device
Intervention Name(s)
COMBO
Other Intervention Name(s)
Combined Sirolimus eluting and endothelial progenitor cell stent
Intervention Description
PCI with COMBO stent
Intervention Type
Device
Intervention Name(s)
ORSIRO
Other Intervention Name(s)
Sirolimus-eluting stent
Intervention Description
PCI with ORSIRO stent
Primary Outcome Measure Information:
Title
Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
Description
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
Time Frame
Within 12 months
Title
Target Lesion Revascularisation (TLR)
Description
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.
Time Frame
Within 12 months
Secondary Outcome Measure Information:
Title
Individual components of the primary end point comprise the secondary end points
Description
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.
Time Frame
Clinical follow-up will be continued through 5 years
Title
Cardiac death
Time Frame
Through 5 years
Title
MI
Description
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.
Time Frame
Through 5 years
Title
Clinically indicated TLR
Description
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.
Time Frame
Through 5 years
Title
All death
Description
Cardiac and noncardiac
Time Frame
Through 5 years
Title
TVR
Description
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.
Time Frame
Through 5 years
Title
Stent thrombosis
Description
Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
Time Frame
Through 5 years
Title
Patient-related composite end point
Description
All death, all MI (including procedure related MI) or any revascularisation
Time Frame
Through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Jakobsen, MD
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital, Department of Cardiology
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet, Hjertecentret
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Unversity Hospital, Department of Cardiology
City
Odense C
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33823606
Citation
Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Ahlehoff O, Christensen MK, Terkelsen CJ, Erik Botker H, Aaroe J, Thim T, Thuesen L, Aziz A, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the Sirolimus-Eluting Orsiro Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT X Trial. Circulation. 2021 Jun;143(22):2155-2165. doi: 10.1161/CIRCULATIONAHA.120.052766. Epub 2021 Apr 7.
Results Reference
derived
PubMed Identifier
29807307
Citation
Jakobsen L, Christiansen EH, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Madsen M, Raungaard B, Jensen SE, Christensen MK, Hansen HS, Jensen LO. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X trial. Am Heart J. 2018 Aug;202:49-53. doi: 10.1016/j.ahj.2018.04.019. Epub 2018 May 5.
Results Reference
derived

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SORT OUT X - Combo Stent Versus ORSIRO Stent

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