Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
NCT ID: NCT01869842
Last Updated: 2013-06-05
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
115 participants
INTERVENTIONAL
2011-12-31
2016-12-31
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
TREATMENT
NONE
Study Groups
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DM, angio group
percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
DM, OCT group
OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
non DM, angio group
percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
non DM, OCT group
OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
Interventions
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percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
Eligibility Criteria
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Inclusion Criteria
* Reference vessel diameter 2.5 - 3.5 mm
* Lesion length ≤ 34 mm and ≤ 34 mm stent length
* Stable angina requiring revascularization, patients with unstable angina
* The patient has no difficulty to enforce the follow-up angiography
* Patient is ≥ 20 years old
Exclusion Criteria
* Reference vessel diameter \< 2.5 mm or \> 4.0mm
* Contraindication to anti-platelet agents
* Treated with any DES within 3 months at other vessel
* Creatinine level ≥ 2.0 mg/dL or ESRD
* Severe hepatic dysfunction (3 times normal reference values)
* Patients with LVEF \< 30%
* Life expectancy 1 year
* Lesions with CTO or left main
* Target vessel of ST-elevation MI
* Lesions requiring overlapped stenting or more than 2 DES in each vessel
* Heavy calcified lesions (definite calcified lesions on angiogram)
* Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
* Pregnant women or women with potential childbearing
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1-2011-0070
Identifier Type: -
Identifier Source: org_study_id
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