The OCT SORT-OUT VIII Study (OCT SORT-OUT)

December 29, 2025 updated by: Evald Hoej Christiansen, Aarhus University Hospital Skejby

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Skejby
      • Odense, Denmark, 5000
        • Odense University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SYNERGY drug eluting stent
Everolimus eluting bioresorbable polymer stent
Device: Everolimus eluting bioresorbable polymer stent
Other Names:
  • SYNERGY
Experimental: Biomatrix NeoFlex drug eluting stent
Biolimus eluting bioresorbable polymer stent
Device: Biolimus eluting bioresorbable polymer stent
Other Names:
  • Biomatrix NeoFlex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Coronary Stent Healing Index
Time Frame: 1 or 3 months
Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
1 or 3 months
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
1 or 3 months
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
1 and 3 months
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
1 and 3 months
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
1 and 3 months
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
1 and 3 months
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)
1 and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Malapposition
Time Frame: Baseline, 1 and 3 months
Detectable separation between the vessel wall and strut in a cross section.
Baseline, 1 and 3 months
Coverage
Time Frame: Baseline, 1 and 3 months
Detectable tissue covering the strut
Baseline, 1 and 3 months
Fracture
Time Frame: Baseline, 1 and 3 months
Discontinuity of a strut evaluated by 3D reconstruction
Baseline, 1 and 3 months
Neointimal thickness (NIT)
Time Frame: Baseline, 1 and 3 months
Thickness of intima from leading strut surface to lumen boarder
Baseline, 1 and 3 months
Lumen area
Time Frame: Baseline, 1 and 3 months
Area of lumen in cross section
Baseline, 1 and 3 months
Stent area
Time Frame: Baseline, 1 and 3 months
Area of stent in cross section
Baseline, 1 and 3 months
Area stenosis (AS) %
Time Frame: Baseline, 1 and 3 months
Minimal luminal area/reference area (interpolated)
Baseline, 1 and 3 months
Minimum expansion of the stent
Time Frame: Baseline, 1 and 3 months
Expressed as absolute area and percentage of the closest reference area
Baseline, 1 and 3 months
Late recoil
Time Frame: Baseline, 1 and 3 months
Loss in stent area from baseline to follow-up
Baseline, 1 and 3 months
Lumen late loss
Time Frame: Baseline, 1 and 3 months
Loss in minimal lumen area from baseline to follow-up
Baseline, 1 and 3 months
Extra stent lumen
Time Frame: Baseline, 1 and 3 months
Area outside stent boarder limited by lumen boarder
Baseline, 1 and 3 months
Evaginations
Time Frame: Baseline, 1 and 3 months
Counts and descriptive by size (volume and depth)
Baseline, 1 and 3 months
Thrombus on struts
Time Frame: Baseline, 1 and 3 months
In final OCT after implantation and at follow-up
Baseline, 1 and 3 months
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
Baseline, 1 and 3 months
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)
Within 12 months
Cardiac death
Time Frame: Baseline, 12, 24, 36, 48 and 60 months
Stent related, major adverse cardiac events (MACE), serious complication at procedure
Baseline, 12, 24, 36, 48 and 60 months
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
Baseline and within 12, 24, 36, 48 and 60 months
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)
Baseline and within 12, 24, 36, 48 and 60 months
All-cause death
Time Frame: 12, 24, 36, 48 and 60 months
12, 24, 36, 48 and 60 months
Stent thrombosis
Time Frame: Baseline, 1, 12, 24, 36, 48 and 60 months
According to ARC criteria
Baseline, 1, 12, 24, 36, 48 and 60 months
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
Baseline
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
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital Skejby

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation
Biosensors International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evald H Christiansen, MD, Aarhus University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-125-14

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings