Status:
UNKNOWN
StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Ischemic Heart Disease
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03401216
Start Date
March 20 2017
End Date
April 30 2019
Last Update
January 17 2018
Active Locations (1)
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1
Academician E.N. Meshalkin national medical research center
Novosibirsk, Russia, 630055