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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-12-31

Brief Summary

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Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.

Detailed Description

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Conditions

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Coronary Artery Disease Stable Angina Unstable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DM, angio group

Group Type ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type PROCEDURE

the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion

DM, OCT group

Group Type EXPERIMENTAL

OCT-guided percutaneous coronary intervention

Intervention Type PROCEDURE

the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion

non DM, angio group

Group Type ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type PROCEDURE

the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion

non DM, OCT group

Group Type EXPERIMENTAL

OCT-guided percutaneous coronary intervention

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

OCT-guided percutaneous coronary intervention

the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion

Intervention Type PROCEDURE

percutaneous coronary intervention

the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion

Intervention Type PROCEDURE

OCT-guided percutaneous coronary intervention

the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Single lesion in a Single vessel
* 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

* Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myeong Ki Hong, Md, PhD

Role: CONTACT

82-2-2228-8460

Facility Contacts

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MyeongKi Hong, MD, PhD

Role: primary

82-2-2228-8460

Other Identifiers

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1-2011-0070

Identifier Type: -

Identifier Source: org_study_id

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