StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation

Study Overview
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Brief Summary
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The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI.

Detailed Description
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Patients with stable, unstable angina and non-ST-elevation ACS will be included in this study. Patient will undergo coronary angiography for coronary anatomy assessment and estimation indications for PCI . After screening an OCT-guided PCI with extra long SYNERGY stent implantation will be provided in all patients. Patient will be divided into 2 groups of follow-up and will be followed within 3 and 6 month after procedure. Final clinical follow-up will be assessed at 12 month for all patients. At each follow-up visits the data regarding clinical events, coronary angiography and OCT-imaging will be collected.

Official Title
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StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation: Prospective sTudy Using optIcal cOhereNce Tomography

Conditions
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Ischemic Heart Disease, Coronary Artery Disease, Coronary Atherosclerosis

Intervention / Treatment
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* Device: SYNERGY 48 mm
* Procedure: PCI
* Procedure: 3 month OCT follow-up
* Procedure: 6 month OCT follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent before study procedures Subject is eligible for percutaneous coronary intervention (PCI) Left ventricular ejection fraction (LVEF) >30% Reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm Target lesion(s) length must be ≥38 mm Target lesion(s) stenosis ≥50% Exclusion Criteria: History of acute or recent stroke (<2 months) Contraindications for antiplatelet and/or anticoagulant therapy Bleeding within the last 30 days Subject has acute ST elevation MI (STEMI) Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support Subject with out of range complete blood count (CBC) values determined as a clinically significant Subject has documented or suspected liver disease, including laboratory evidence of hepatitis Subject has baseline serum creatinine level >2.0 mg/dL (177µmol/L) Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) Lesion located within a saphenous vein graft or an arterial graft Subject has unprotected left main coronary artery disease (>50% diameter stenosis) Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: 80 patients, that underwent PCI with Synergy 48 mm stent implantation, will be randomized into 2 groups of follow-up OCT-visualization - 3 and 6 month.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNERGY 48 PCI + 3 month OCT follow-up<br>Synergy 48 mm stent implantation followed by 3 month OCT imaging | Device: SYNERGY 48 mm<br>* Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA)<br>Procedure: PCI<br>* Standard PCI procedure<br>Procedure: 3 month OCT follow-up<br>* Optical coherence tomography imaging of target vessel within 3 month after PCI<br>|
| Experimental: SYNERGY 48 PCI + 6 month OCT follow-up<br>Synergy 48 mm stent implantation followed by 6 month OCT imaging | Device: SYNERGY 48 mm<br>* Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA)<br>Procedure: PCI<br>* Standard PCI procedure<br>Procedure: 6 month OCT follow-up<br>* Optical coherence tomography imaging of target vessel within 5 month after PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal healing score | The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level: Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of 4. Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of 3 Presence of uncovered struts alone (% malapposed, M) is assigned a weight of 2 Presence of malapposed struts alone (% uncovered, U) is assigned a weight of 1 | within 3 month after PCI | 
| Neointimal healing score | The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level: Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of 4. Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of 3 Presence of uncovered struts alone (% malapposed, M) is assigned a weight of 2 Presence of malapposed struts alone (% uncovered, U) is assigned a weight of 1 | within 6 month after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of strut coverage assessed by OCT | In metallic DES, the struts are classified as covered in the presence of a coverage thickness >0 μm (tissue can be identified above the struts). | within 3 month after PCI | 
| Percentage of strut coverage assessed by OCT | In metallic DES, the struts are classified as covered in the presence of a coverage thickness >0 μm (tissue can be identified above the struts). | within 6 month after PCI | 
| Percentage of mature neointimal tissue assessed by OCT | To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed. | within 3 month after PCI | 
| Percentage of mature neointimal tissue assessed by OCT | To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed. | within 6 month after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical coherence tomography, Healing score, Neointimal coverage, synergy 48, long lesion