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

November 25, 2023 updated by: Lars Jakobsen, Aarhus University Hospital Skejby

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg University Hospital, Department of Cardiology
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital, Skejby
      • København, Denmark, 2100
        • Rigshospitalet, Hjertecentret
      • Odense C, Denmark, 5000
        • Odense Unversity Hospital, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COMBO
PCI with COMBO stent
Device: COMBO
PCI with COMBO stent
Other Names:
  • Combined Sirolimus eluting and endothelial progenitor cell stent
Active Comparator: ORSIRO
PCI with ORSIRO stent
Device: ORSIRO
PCI with ORSIRO stent
Other Names:
  • Sirolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Revascularisation (TLR)
Time Frame: 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.
Within 12 months
Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
Time Frame: 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
Within 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual components of the primary end point comprise the secondary end points
Time Frame: 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.
Clinical follow-up will be continued through 5 years
Cardiac death
Time Frame: Through 5 years
Through 5 years
MI
Time Frame: 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.
Through 5 years
Clinically indicated TLR
Time Frame: 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.
Through 5 years
All death
Time Frame: Through 5 years
Cardiac and noncardiac
Through 5 years
TVR
Time Frame: 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.
Through 5 years
Stent thrombosis
Time Frame: Through 5 years
Definite, probable, possible and overall according to the Academic Research Consortium definition (22)
Through 5 years
Patient-related composite end point
Time Frame: Through 5 years
All death, all MI (including procedure related MI) or any revascularisation
Through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Biotronik SE & Co. KG
OrbusNeich

Investigators

  • Principal Investigator: Lars Jakobsen, MD, Aarhus University Hospital Skejby

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 25, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-38-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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