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

Primary Purpose

Coronary Artery Disease, Angina Pectoris, Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Everolimus eluting bioresorbable polymer stent
Biolimus eluting bioresorbable polymer stent
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring DES, Angina pectoris, Stent, Optical coherence tomography, Stent thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aarhus University Hospital, Skejby
  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SYNERGY drug eluting stent

Biomatrix NeoFlex drug eluting stent

Arm Description

Everolimus eluting bioresorbable polymer stent

Biolimus eluting bioresorbable polymer stent

Outcomes

Primary Outcome Measures

Coronary Stent Healing Index
Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
Uncovered stent struts
Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9
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
Persistent malapposition
Persistent malapposition: >2 adjacent struts of at least 1 mm length =1; >2 mm=2; >3 mm=3
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
Acquired malapposition
Acquired malapposition: >2 adjacent struts of at least 1 mm length =2; > 2 mm=4; > 3 mm=6
Cumulated extra stent lumen increase in matched cross sectional analysis
Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)

Secondary Outcome Measures

Malapposition
Detectable separation between the vessel wall and strut in a cross section.
Coverage
Detectable tissue covering the strut
Fracture
Discontinuity of a strut evaluated by 3D reconstruction
Neointimal thickness (NIT)
Thickness of intima from leading strut surface to lumen boarder
Lumen area
Area of lumen in cross section
Stent area
Area of stent in cross section
Area stenosis (AS) %
Minimal luminal area/reference area (interpolated)
Minimum expansion of the stent
Expressed as absolute area and percentage of the closest reference area
Late recoil
Loss in stent area from baseline to follow-up
Lumen late loss
Loss in minimal lumen area from baseline to follow-up
Extra stent lumen
Area outside stent boarder limited by lumen boarder
Evaginations
Counts and descriptive by size (volume and depth)
Thrombus on struts
In final OCT after implantation and at follow-up
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
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)
Cardiac death
Stent related, major adverse cardiac events (MACE), serious complication at procedure
Non-index procedure related acute myocardial infarction (AMI)
Defined as AMI not clearly related to another lesion than the target lesion
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)
All-cause death
Stent thrombosis
According to ARC criteria
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
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

Full Information

First Posted
September 9, 2014
Last Updated
October 17, 2022
Sponsor
Aarhus University Hospital Skejby
Collaborators
Biosensors International, Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02253108
Brief Title
The OCT SORT-OUT VIII Study
Acronym
OCT SORT-OUT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Biosensors International, Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
Keywords
DES, Angina pectoris, Stent, Optical coherence tomography, Stent thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SYNERGY drug eluting stent
Arm Type
Experimental
Arm Description
Everolimus eluting bioresorbable polymer stent
Arm Title
Biomatrix NeoFlex drug eluting stent
Arm Type
Experimental
Arm Description
Biolimus eluting bioresorbable polymer stent
Intervention Type
Device
Intervention Name(s)
Everolimus eluting bioresorbable polymer stent
Other Intervention Name(s)
SYNERGY
Intervention Type
Device
Intervention Name(s)
Biolimus eluting bioresorbable polymer stent
Other Intervention Name(s)
Biomatrix NeoFlex
Primary Outcome Measure Information:
Title
Coronary Stent Healing Index
Description
Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
Time Frame
1 or 3 months
Title
Uncovered stent struts
Description
Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9
Time Frame
1 or 3 months
Title
Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts
Description
Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0
Time Frame
1 and 3 months
Title
Persistent malapposition
Description
Persistent malapposition: >2 adjacent struts of at least 1 mm length =1; >2 mm=2; >3 mm=3
Time Frame
1 and 3 months
Title
Neointimal thickness in one frame or lumen mean diameter stenosis
Description
Neointimal thickness in one frame or lumen mean diameter stenosis >200=1; >300=2; >400=3 or diameter stenosis >50%=4; >75%=5
Time Frame
1 and 3 months
Title
Acquired malapposition
Description
Acquired malapposition: >2 adjacent struts of at least 1 mm length =2; > 2 mm=4; > 3 mm=6
Time Frame
1 and 3 months
Title
Cumulated extra stent lumen increase in matched cross sectional analysis
Description
Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)
Time Frame
1 and 3 months
Secondary Outcome Measure Information:
Title
Malapposition
Description
Detectable separation between the vessel wall and strut in a cross section.
Time Frame
Baseline, 1 and 3 months
Title
Coverage
Description
Detectable tissue covering the strut
Time Frame
Baseline, 1 and 3 months
Title
Fracture
Description
Discontinuity of a strut evaluated by 3D reconstruction
Time Frame
Baseline, 1 and 3 months
Title
Neointimal thickness (NIT)
Description
Thickness of intima from leading strut surface to lumen boarder
Time Frame
Baseline, 1 and 3 months
Title
Lumen area
Description
Area of lumen in cross section
Time Frame
Baseline, 1 and 3 months
Title
Stent area
Description
Area of stent in cross section
Time Frame
Baseline, 1 and 3 months
Title
Area stenosis (AS) %
Description
Minimal luminal area/reference area (interpolated)
Time Frame
Baseline, 1 and 3 months
Title
Minimum expansion of the stent
Description
Expressed as absolute area and percentage of the closest reference area
Time Frame
Baseline, 1 and 3 months
Title
Late recoil
Description
Loss in stent area from baseline to follow-up
Time Frame
Baseline, 1 and 3 months
Title
Lumen late loss
Description
Loss in minimal lumen area from baseline to follow-up
Time Frame
Baseline, 1 and 3 months
Title
Extra stent lumen
Description
Area outside stent boarder limited by lumen boarder
Time Frame
Baseline, 1 and 3 months
Title
Evaginations
Description
Counts and descriptive by size (volume and depth)
Time Frame
Baseline, 1 and 3 months
Title
Thrombus on struts
Description
In final OCT after implantation and at follow-up
Time Frame
Baseline, 1 and 3 months
Title
Acute expansion and late recoil
Description
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
Time Frame
Baseline, 1 and 3 months
Title
Target Lesion Failure (TLF)
Description
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)
Time Frame
Within 12 months
Title
Cardiac death
Description
Stent related, major adverse cardiac events (MACE), serious complication at procedure
Time Frame
Baseline, 12, 24, 36, 48 and 60 months
Title
Non-index procedure related acute myocardial infarction (AMI)
Description
Defined as AMI not clearly related to another lesion than the target lesion
Time Frame
Baseline and within 12, 24, 36, 48 and 60 months
Title
Target Lesion Revascularisation (TLR)
Description
New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal)
Time Frame
Baseline and within 12, 24, 36, 48 and 60 months
Title
All-cause death
Time Frame
12, 24, 36, 48 and 60 months
Title
Stent thrombosis
Description
According to ARC criteria
Time Frame
Baseline, 1, 12, 24, 36, 48 and 60 months
Title
Device success rate
Description
Defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated
Time Frame
Baseline
Title
Procedural success rate
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evald H Christiansen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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The OCT SORT-OUT VIII Study

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