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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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)
Standard PCI procedure
Optical coherence tomography imaging of target vessel within 3 month after PCI
Academician E.N. Meshalkin national medical research center
Novosibirsk, Russia
RECRUITINGNeointimal 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"
Time frame: 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"
Time frame: within 6 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).
Time frame: 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).
Time frame: 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.
Time frame: within 3 month after PCI
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Optical coherence tomography imaging of target vessel within 5 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.
Time frame: within 6 month after PCI