StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
NCT ID: NCT03401216
Last Updated: 2018-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-03-20
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SYNERGY 48 PCI + 3 month OCT follow-up
Synergy 48 mm stent implantation followed by 3 month OCT imaging
SYNERGY 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)
PCI
Standard PCI procedure
3 month OCT follow-up
Optical coherence tomography imaging of target vessel within 3 month after PCI
SYNERGY 48 PCI + 6 month OCT follow-up
Synergy 48 mm stent implantation followed by 6 month OCT imaging
SYNERGY 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)
PCI
Standard PCI procedure
6 month OCT follow-up
Optical coherence tomography imaging of target vessel within 5 month after PCI
Interventions
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SYNERGY 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)
PCI
Standard PCI procedure
3 month OCT follow-up
Optical coherence tomography imaging of target vessel within 3 month after PCI
6 month OCT follow-up
Optical coherence tomography imaging of target vessel within 5 month after PCI
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Locations
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Academician E.N. Meshalkin national medical research center
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Exeption
Identifier Type: -
Identifier Source: org_study_id
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