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Coronary Heart DiseaseSORT OUT XNCT03216733

SORT OUT X - Combo Stent Versus ORSIRO Stent

A study testing COMBO and ORSIRO in people with Coronary Heart Disease and Angina Pectoris, run by Aarhus University Hospital Skejby at 4 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
COMBO and ORSIRO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,148 participants
Where
4 sitesDenmark
Study dates
1 Jun 2017to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Life expectancy <1 year
  • Allergic to aspirin, clopidogrel, prasugrel or ticagrelor
  • Allergic to sirolimus

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Aalborg University Hospital, Department of Cardiology

    Aalborg, 9100

  • Aarhus University Hospital, Skejby

    Aarhus N, 8200

  • Rigshospitalet, Hjertecentret

    Copenhagen, 2100

  • Odense Unversity Hospital, Department of Cardiology

    Odense C, 5000

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
COMBO, ORSIRO
Keywords
DES, Angina pectoris, Stent
Medical subject headings
Coronary Disease, Angina Pectoris, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMBODevice

    Also called Combined Sirolimus eluting and endothelial progenitor cell stent

    PCI with COMBO stent

  • ORSIRODevice

    Also called Sirolimus-eluting stent

    PCI with ORSIRO stent

Study groups in NCT03216733
Study groupRoleWhat they receive
COMBOExperimentalPCI with COMBO stent
Receives: Device: COMBO
ORSIROActive comparatorPCI with ORSIRO stent
Receives: Device: ORSIRO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 12 months

  2. 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.

    Measured: Within 12 months

Secondary outcomes (8)

  1. 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.

    Measured: Clinical follow-up will be continued through 5 years

  2. Cardiac death

    Measured: Through 5 years

  3. 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.

    Measured: Through 5 years

  4. 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.

    Measured: Through 5 years

  5. All death

    Cardiac and noncardiac

    Measured: Through 5 years

  6. 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.

    Measured: Through 5 years

  7. Stent thrombosis

    Definite, probable, possible and overall according to the Academic Research Consortium definition (22)

    Measured: Through 5 years

  8. Patient-related composite end point

    All death, all MI (including procedure related MI) or any revascularisation

    Measured: Through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start1 Jun 2017
  3. Primary completion30 Nov 2018
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216733
Sponsor's protocol ID
1-10-72-38-17
Acronym
SORT OUT X
Status last verified
Nov 2023
First submitted
4 Jul 2017
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, Raungaard B, Ellert J, Villadsen AB, Kristensen SD, Christensen MK, Terkelsen CJ, Aaroe J, Thim T, Lassen JF, Hougaard M, Eftekhari A, Jensen RV, Stottrup NB, Rasmussen JG, Junker A, Jensen SE, Hansen HS, Jensen LO. Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial. EuroIntervention. 2023 Oct 23;19(8):676-683. doi: 10.4244/EIJ-D-23-00330.

    PubMed 37584207

  • 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.

    PubMed 33823606

  • 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.

    PubMed 29807307

Questions about this trial

What is this clinical trial studying?

A study testing COMBO and ORSIRO in people with Coronary Heart Disease and Angina Pectoris, run by Aarhus University Hospital Skejby at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216733, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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