Status:
UNKNOWN
Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation
Lead Sponsor:
Fujita Health University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain...
Detailed Description
Intracoronary imaging techniques provide clinically useful information in the setting of PCI, such as lesion severity, tissue characterization, vessel sizing, and stent optimization. Current evidences...
Eligibility Criteria
Inclusion
- Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.
Exclusion
- Renal insufficiency with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2
- Left ventricular ejection fraction (LVEF) \<30% or history of congestive heart failure
- Acute coronary syndrome within 7 days after onset
- Considered as inappropriate for drug-eluting stent (DES) use or dual antiplatelet therapy for one year after the index procedure
- Life expectancy within one year
- Lesion length estimated by quantitative coronary angiography (QCA) \>28mm
- Chronic total occlusion
- Left main stem lesion
- Bifurcation requiring side branch balloon dilatation
- Severely calcified lesion
- Other conditions by which physicians in charge judged inappropriate to enroll the patients because of safety concern.
Key Trial Info
Start Date :
June 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2017
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03292081
Start Date
June 12 2014
End Date
October 25 2017
Last Update
September 25 2017
Active Locations (1)
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1
Fujita Health University
Toyoake, Japan, 470-1192