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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNERGY 48 PCI + 3 month OCT follow-up | Experimental | Synergy 48 mm stent implantation followed by 3 month OCT imaging |
|
| SYNERGY 48 PCI + 6 month OCT follow-up | Experimental | Synergy 48 mm stent implantation followed by 6 month OCT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNERGY 48 mm | Device | 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) |
| 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:
| 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:
| within 6 month after PCI |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure (TLF) | TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. | 12 month after PCI |
| Cardiac death |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksei Prokhorikhin, MD | Contact | +79137178040 | turbogold@list.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academician E.N. Meshalkin national medical research center | Recruiting | Novosibirsk | 630055 | Russia |
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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.
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|
| PCI | Procedure | Standard PCI procedure |
|
| 3 month OCT follow-up | Procedure | Optical coherence tomography imaging of target vessel within 3 month after PCI |
|
| 6 month OCT follow-up | Procedure | Optical coherence tomography imaging of target vessel within 5 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). |
| 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 |
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.
| 12 month after PCI |
| Myocardial infarction | Type 1, 2, 3, 4a, 4b according to Third Universal Definition of Myocardial Infarction | 12 month after PCI |
| Stent thrombosis | Definite and probable, according to ARC definition, | 12 month after PCI |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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