Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
NCT ID: NCT02814578
Last Updated: 2018-09-06
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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TERMINATED
NA
9 participants
INTERVENTIONAL
2017-07-31
2017-07-31
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
DIAGNOSTIC
NONE
Study Groups
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Optical coherent tomography
Optical coherent tomography provides more detailed information about the morphology of scaffolds, microstructures and coronary vasculature based on tissue characteristics as compared to conventional IVUS. In spite of angiographic success in BVS placement, further scaffold optimization was required in over a quarter of cases based on OCT findings due to malapposition or scaffold under expansion.
Optical coherent tomography
comparative method for BVS
IntraVascular UltraSound
Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.
IntraVascular UltraSound
The method of goldstandard for decision stent choice
Interventions
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Optical coherent tomography
comparative method for BVS
IntraVascular UltraSound
The method of goldstandard for decision stent choice
Eligibility Criteria
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Inclusion Criteria
* Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia
* Willing and able to provide informed written consent
* Eligible for PCI
Exclusion Criteria
* Bypass graft lesion
* Lesion with left main disease
* Expected length of scaffold \> 40 mm
* Bifurcation lesion requiring side branch stenting
* Small vessels \< 2.75 mm
* Stented lesion
* Suspected coronary spasm even after sufficient nitrate injected
* Cases in which the IVUS or OCT imaging catheter failed to cross the lesion
* Poor quality IVUS or OCT images
* Contraindication to dual anti-platelet therapy
* Chronic total occlusion
* Angiographically large-sized vessel (\>3.5mm of reference lumen diameter)
* Life expectancy shorter than 2 years
* Pregnancy
20 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Young-Hak Kim, MD, PhD
OTHER
Responsible Party
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Young-Hak Kim, MD, PhD
Professor in medicine
Locations
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Asan Medical Center
Seoul, Songpa-Gu, South Korea
Pusan National University Hospital
Pusan, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Other Identifiers
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AMCCV2016-02
Identifier Type: -
Identifier Source: org_study_id
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