Coronary Artery Disease, Coronary Atherosclerosis, Ischemic Heart Disease
Conditions
Keywords
Optical coherence tomography, Healing score, Neointimal coverage, synergy 48, long lesion
Brief summary
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
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.
Interventions
DEVICESYNERGY 48 mm
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)
PROCEDUREPCI
Standard PCI procedure
PROCEDURE3 month OCT follow-up
Optical coherence tomography imaging of target vessel within 3 month after PCI
PROCEDURE6 month OCT follow-up
Optical coherence tomography imaging of target vessel within 5 month after PCI
Sponsors
Boston Scientific Corporation
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal healing score | within 3 month after PCI | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of strut coverage assessed by OCT | within 3 month after PCI | 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). |
| Percentage of mature neointimal tissue assessed by OCT | within 3 month after PCI | To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF) | 12 month after PCI | TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. |
| Stent thrombosis | 12 month after PCI | Definite and probable, according to ARC definition, |
| Cardiac death | 12 month after PCI | Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. |
| Myocardial infarction | 12 month after PCI | Type 1, 2, 3, 4a, 4b according to Third Universal Definition of Myocardial Infarction |
Countries
Russia
Contacts
Primary ContactAleksei Prokhorikhin, MD
Outcome results
None listed