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Active, Not Recruiting

NCT Number: NCT02253108

The OCT SORT-OUT VIII Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Skejby, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Age <18 years
  • Do not wish to participate
  • Unable to provide written informed consent
  • Domicile outside Denmark
  • Do not speak Danish
  • Inclusion in the SORT-OUT VIII study
  • Inclusion in other stent studies
  • 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)

Treatment and study plan

Everolimus eluting bioresorbable polymer stent

Device

Other names: SYNERGY

Biolimus eluting bioresorbable polymer stent

Device

Other names: Biomatrix NeoFlex

Primary outcomes

  1. Coronary Stent Healing Index

    Time frame: 1 or 3 months

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

  2. Uncovered stent struts

    Time frame: 1 or 3 months

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

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

    Time frame: 1 and 3 months

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

  4. Persistent malapposition

    Time frame: 1 and 3 months

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

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

    Time frame: 1 and 3 months

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

  6. Acquired malapposition

    Time frame: 1 and 3 months

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

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

    Time frame: 1 and 3 months

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

Secondary outcomes

  1. Malapposition

    Time frame: Baseline, 1 and 3 months

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

  2. Coverage

    Time frame: Baseline, 1 and 3 months

    Detectable tissue covering the strut

  3. Fracture

    Time frame: Baseline, 1 and 3 months

    Discontinuity of a strut evaluated by 3D reconstruction

  4. Neointimal thickness (NIT)

    Time frame: Baseline, 1 and 3 months

    Thickness of intima from leading strut surface to lumen boarder

  5. Lumen area

    Time frame: Baseline, 1 and 3 months

    Area of lumen in cross section

  6. Stent area

    Time frame: Baseline, 1 and 3 months

    Area of stent in cross section

  7. Area stenosis (AS) %

    Time frame: Baseline, 1 and 3 months

    Minimal luminal area/reference area (interpolated)

  8. Minimum expansion of the stent

    Time frame: Baseline, 1 and 3 months

    Expressed as absolute area and percentage of the closest reference area

  9. Late recoil

    Time frame: Baseline, 1 and 3 months

    Loss in stent area from baseline to follow-up

  10. Lumen late loss

    Time frame: Baseline, 1 and 3 months

    Loss in minimal lumen area from baseline to follow-up

  11. Extra stent lumen

    Time frame: Baseline, 1 and 3 months

    Area outside stent boarder limited by lumen boarder

  12. Evaginations

    Time frame: Baseline, 1 and 3 months

    Counts and descriptive by size (volume and depth)

  13. Thrombus on struts

    Time frame: Baseline, 1 and 3 months

    In final OCT after implantation and at follow-up

  14. Acute expansion and late recoil

    Time frame: Baseline, 1 and 3 months

    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

  15. Target Lesion Failure (TLF)

    Time frame: Within 12 months

    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)

  16. Cardiac death

    Time frame: Baseline, 12, 24, 36, 48 and 60 months

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

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

    Time frame: Baseline and within 12, 24, 36, 48 and 60 months

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

  18. Target Lesion Revascularisation (TLR)

    Time frame: Baseline and within 12, 24, 36, 48 and 60 months

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

  19. All-cause death

    Time frame: 12, 24, 36, 48 and 60 months

  20. Stent thrombosis

    Time frame: Baseline, 1, 12, 24, 36, 48 and 60 months

    According to ARC criteria

  21. Device success rate

    Time frame: Baseline

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

  22. Procedural success rate

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Biosensors International
  • Boston Scientific Corporation

Registry information

Official study 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

Acronym: OCT SORT-OUT

Important dates

Study start
2014
Primary completion
2015
Study completion
2026
First posted
Oct 1, 2014
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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