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

June 4, 2013 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Myeong Ki Hong, Md, PhD
  • Phone Number: 82-2-2228-8460
  • Email: mkhong61@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
        • Principal Investigator:
          • Myeong Ki Hong, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DM, angio group
Procedure: percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
Experimental: DM, OCT group
Procedure: OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
Active Comparator: non DM, angio group
Procedure: percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
Experimental: non DM, OCT group
Procedure: OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ratio of the stent strut
Time Frame: Angiographic follow-up with OCT at 6 months
Angiographic follow-up with OCT at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 31, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2011-0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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