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Coronary Artery DiseaseSORTOUTXINCT03952273

Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

A study testing PCI with BioMatrix Alpha™ stent and PCI with Combo™ stent in people with Coronary Artery Disease, run by Phillip Freeman at 2 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

SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PCI with BioMatrix Alpha™ stent and PCI with Combo™ stent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,141 participants
Where
2 sitesDenmark
Study dates
14 Aug 2019to 30 Nov 2030
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 one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.

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 the SORT OUT XI study
  • Life expectancy <1 year
  • Allergic to study related treatment

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Aarhus University Hospital, Skejby

    Aarhus, 8200

  • Odense Unversity Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: Randomized Clinical Comparison of the Combined Sirolimus Eluting and Endothelial Progenitor Cell Combo™ Stent and the Biolimus Eluting Absorbable Polymer Coated BioMatrix Alpha™ Stent in Patients Treated With Percutaneous Coronary Intervention.

SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.

Read the detailed description

Randomized clinical comparison of the Sirolimus eluting and endothelial progenitor cell Combo™ stent and the Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent in patients treated with percutaneous coronary intervention

Being tested
PCI with BioMatrix Alpha™ stent, PCI with Combo™ stent
Keywords
Drug eluting stent, Stent
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • PCI with BioMatrix Alpha™ stentCombination product

    Also called Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

    Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

  • PCI with Combo™ stentCombination product

    Also called Combined sirolimus eluting and endothelial progenitor cell Combo™ stent

    Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent

Study groups in NCT03952273
Study groupRoleWhat they receive
ComboActive comparatorPCI with COMBO stent
Receives: Combination Product: PCI with Combo™ stent
BioMatrix AlphaActive comparatorPCI with BioMatrix Alpha stent
Receives: Combination Product: PCI with BioMatrix Alpha™ stent

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

    The primary endpoint will be analyzed using 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 ComboTM 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. Number of participants with Cardiac Death

    Measured: Through 5 years

  3. Number of participants with Myocardial Infarction

    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. Target Lesion Revascularization due to clincal symptoms

    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. Number of patients with all cause mortality

    Cardiac and non-cardiac

    Measured: Through 5 years

  6. Target Vessel Revascularization due to clincal symptoms

    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. Number of patients with stent thrombosis

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

    Measured: Through 5 years

  8. Number of patients with 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 posted16 May 2019
  2. Study start14 Aug 2019
  3. Primary completion19 Mar 2023
  4. Study completion30 Nov 2030 (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
3,141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03952273
Sponsor's protocol ID
Sort Out XI
Acronym
SORTOUTXI
Status last verified
Apr 2023
First submitted
10 May 2019
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only shared with collaborators

Publications

  • Eftekhari A, Jensen LO, Veien K, Raungaard B, Rasmussen JG, Maeng M, Terkelsen CJ, Ellert-Gregersen J, Stottrup NB, Lassen JF, Hansen HS, Thim T, Jensen RV, Nielsen R, Jensen SE, Kristensen SD, Hougaard M, Junker A, Christensen MK, Aaroe J, Froslev T, Jakobsen L, Christiansen EH. Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial. J Am Coll Cardiol. 2025 Jul 15;86(2):106-115. doi: 10.1016/j.jacc.2025.05.012. Epub 2025 May 21.

    PubMed 40406942

  • Eftekhari A, Christiansen EH, Lassen JF, Raungaard B, Jakobsen L, Jensen LO. Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial. Am Heart J. 2025 May;283:37-42. doi: 10.1016/j.ahj.2025.01.012. Epub 2025 Jan 25.

    PubMed 39870125

Questions about this trial

What is this clinical trial studying?

A study testing PCI with BioMatrix Alpha™ stent and PCI with Combo™ stent in people with Coronary Artery Disease, run by Phillip Freeman at 2 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 1 inclusion and 7 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 NCT03952273, which also lists 2 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 26 Apr 2023; AzTrials last refreshed its copy on 2 Nov 2026.

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