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Coronary Artery DiseaseOCT SORT-OUTNCT02253108

The OCT SORT-OUT VIII Study

A study testing Everolimus eluting bioresorbable polymer stent and Biolimus eluting bioresorbable polymer stent in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby 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

The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Everolimus eluting bioresorbable polymer stent and Biolimus eluting bioresorbable polymer stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesDenmark
Study dates
May 2014to Jun 2026
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

  • Patients >18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital
  • Expected survival <1 year
  • Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
  • Hypersensitivity to everolimus or biolimus
  • The operator wishes to use other DES
  • Reduced renal function; creatinine> 120 mmol / L
  • Only bare metal stent (BMS) implantation
  • Only plain old balloon angioplasty (POBA)

Who cannot join

  • Age <18 years
  • Do not wish to participate
  • Unable to provide written informed consent
  • Domicile outside Denmark
  • Do not speak Danish

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Aarhus University Hospital, Skejby

    Aarhus, 8200

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: Randomized Comparison of the Biolimus-eluting Biomatrix Neoflex™ og Everolimus-eluting SYNERGY™ Stents in All-comer Patients With Ischemic Heart Disease - The OCT SORT-OUT VIII

The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.

Read the detailed description

Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.

Being tested
Everolimus eluting bioresorbable polymer stent, Biolimus eluting bioresorbable polymer stent
Keywords
DES, Angina pectoris, Stent, Optical coherence tomography, Stent thrombosis
Medical subject headings
Coronary Artery Disease, Angina Pectoris, Myocardial Infarction

What participants receive

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

  • Everolimus eluting bioresorbable polymer stentDevice

    Also called SYNERGY

  • Biolimus eluting bioresorbable polymer stentDevice

    Also called Biomatrix NeoFlex

Study groups in NCT02253108
Study groupRoleWhat they receive
SYNERGY drug eluting stentExperimentalEverolimus eluting bioresorbable polymer stent
Receives: Device: Everolimus eluting bioresorbable polymer stent
Biomatrix NeoFlex drug eluting stentExperimentalBiolimus eluting bioresorbable polymer stent
Receives: Device: Biolimus eluting bioresorbable polymer stent

What is being measured

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

  1. Coronary Stent Healing Index

    Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)

    Measured: 1 or 3 months

  2. Uncovered stent struts

    Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9

    Measured: 1 or 3 months

  3. Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts

    Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0

    Measured: 1 and 3 months

  4. Persistent malapposition

    Persistent malapposition: >2 adjacent struts of at least 1 mm length =1; >2 mm=2; >3 mm=3

    Measured: 1 and 3 months

  5. Neointimal thickness in one frame or lumen mean diameter stenosis

    Neointimal thickness in one frame or lumen mean diameter stenosis >200=1; >300=2; >400=3 or diameter stenosis >50%=4; >75%=5

    Measured: 1 and 3 months

  6. Acquired malapposition

    Acquired malapposition: >2 adjacent struts of at least 1 mm length =2; > 2 mm=4; > 3 mm=6

    Measured: 1 and 3 months

  7. Cumulated extra stent lumen increase in matched cross sectional analysis

    Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)

    Measured: 1 and 3 months

Secondary outcomes (22)

  1. Malapposition

    Detectable separation between the vessel wall and strut in a cross section.

    Measured: Baseline, 1 and 3 months

  2. Coverage

    Detectable tissue covering the strut

    Measured: Baseline, 1 and 3 months

  3. Fracture

    Discontinuity of a strut evaluated by 3D reconstruction

    Measured: Baseline, 1 and 3 months

  4. Neointimal thickness (NIT)

    Thickness of intima from leading strut surface to lumen boarder

    Measured: Baseline, 1 and 3 months

  5. Lumen area

    Area of lumen in cross section

    Measured: Baseline, 1 and 3 months

  6. Stent area

    Area of stent in cross section

    Measured: Baseline, 1 and 3 months

  7. Area stenosis (AS) %

    Minimal luminal area/reference area (interpolated)

    Measured: Baseline, 1 and 3 months

  8. Minimum expansion of the stent

    Expressed as absolute area and percentage of the closest reference area

    Measured: Baseline, 1 and 3 months

  9. Late recoil

    Loss in stent area from baseline to follow-up

    Measured: Baseline, 1 and 3 months

  10. Lumen late loss

    Loss in minimal lumen area from baseline to follow-up

    Measured: Baseline, 1 and 3 months

  11. Extra stent lumen

    Area outside stent boarder limited by lumen boarder

    Measured: Baseline, 1 and 3 months

  12. Evaginations

    Counts and descriptive by size (volume and depth)

    Measured: Baseline, 1 and 3 months

  13. Thrombus on struts

    In final OCT after implantation and at follow-up

    Measured: Baseline, 1 and 3 months

  14. Acute expansion and late recoil

    In segments with; 1)calcified plaque, 2)lipid plaque, 3)area after predilatation <30% of reference area, 4)stenosed segments (>50% AS) with no dissections after predilatation

    Measured: Baseline, 1 and 3 months

  15. Target Lesion Failure (TLF)

    Stent related combined endpoint of Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related AMI (defined as AMI not clearly related to another lesion than the target lesion), or Target Lesion Revascularisation (TLR) (by PCI or CABG - TLR if significant stenosis + 5mm distal/proximal)

    Measured: Within 12 months

  16. Cardiac death

    Stent related, major adverse cardiac events (MACE), serious complication at procedure

    Measured: Baseline, 12, 24, 36, 48 and 60 months

  17. Non-index procedure related acute myocardial infarction (AMI)

    Defined as AMI not clearly related to another lesion than the target lesion

    Measured: Baseline and within 12, 24, 36, 48 and 60 months

  18. Target Lesion Revascularisation (TLR)

    New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal)

    Measured: Baseline and within 12, 24, 36, 48 and 60 months

  19. All-cause death

    Measured: 12, 24, 36, 48 and 60 months

  20. Stent thrombosis

    According to ARC criteria

    Measured: Baseline, 1, 12, 24, 36, 48 and 60 months

  21. Device success rate

    Defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated

    Measured: Baseline

  22. Procedural success rate

    Defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated and without serious complications

    Measured: Baseline

Timeline

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

  1. First posted1 Oct 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionApr 2015
  4. Study completionJun 2026 (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
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02253108
Sponsor's protocol ID
1-10-72-125-14
Acronym
OCT SORT-OUT
Status last verified
Dec 2025
First submitted
9 Sep 2014
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Everolimus eluting bioresorbable polymer stent and Biolimus eluting bioresorbable polymer stent in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby 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 8 inclusion and 5 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 2 Jan 2026. 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?

Coronary Stent Healing Index (time frame: 1 or 3 months). The study lists 7 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 NCT02253108.

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 2 Jan 2026.

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