The OCT SORT-OUT VIII Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Angina Pectoris, Myocardial Infarction

Intervention / Treatment
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* Device: Everolimus eluting bioresorbable polymer stent
* Device: Biolimus eluting bioresorbable polymer stent


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNERGY drug eluting stent<br>Everolimus eluting bioresorbable polymer stent | Device: Everolimus eluting bioresorbable polymer stent<br> <br> * Other names: SYNERGY;|
| Experimental: Biomatrix NeoFlex drug eluting stent<br>Biolimus eluting bioresorbable polymer stent | Device: Biolimus eluting bioresorbable polymer stent<br> <br> * Other names: Biomatrix NeoFlex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary Stent Healing Index | Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT) | 1 or 3 months | 
| Uncovered stent struts | 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 | 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 | 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 | 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 | 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 | Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area) | 1 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malapposition | Detectable separation between the vessel wall and strut in a cross section. | Baseline, 1 and 3 months | 
| Coverage | Detectable tissue covering the strut | Baseline, 1 and 3 months | 
| Fracture | Discontinuity of a strut evaluated by 3D reconstruction | Baseline, 1 and 3 months | 
| Neointimal thickness (NIT) | Thickness of intima from leading strut surface to lumen boarder | Baseline, 1 and 3 months | 
| Lumen area | Area of lumen in cross section | Baseline, 1 and 3 months | 
| Stent area | Area of stent in cross section | Baseline, 1 and 3 months | 
| Area stenosis (AS) % | Minimal luminal area/reference area (interpolated) | Baseline, 1 and 3 months | 
| Minimum expansion of the stent | Expressed as absolute area and percentage of the closest reference area | Baseline, 1 and 3 months | 
| Late recoil | Loss in stent area from baseline to follow-up | Baseline, 1 and 3 months | 
| Lumen late loss | Loss in minimal lumen area from baseline to follow-up | Baseline, 1 and 3 months | 
| Extra stent lumen | Area outside stent boarder limited by lumen boarder | Baseline, 1 and 3 months | 
| Evaginations | Counts and descriptive by size (volume and depth) | Baseline, 1 and 3 months | 
| Thrombus on struts | In final OCT after implantation and at follow-up | Baseline, 1 and 3 months | 
| 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 | Baseline, 1 and 3 months | 
| 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) | Within 12 months | 
| Cardiac death | 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) | 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) | 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 |  | 12, 24, 36, 48 and 60 months | 
| Stent thrombosis | According to ARC criteria | Baseline, 1, 12, 24, 36, 48 and 60 months | 
| 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 | Baseline | 
| 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 | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, Angina pectoris, Stent, Optical coherence tomography, Stent thrombosis