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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

Primary Purpose

Coronary Artery Disease, Stable Angina, Unstable Angina

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
percutaneous coronary intervention
OCT-guided percutaneous coronary intervention
percutaneous coronary intervention
OCT-guided percutaneous coronary intervention
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Resolute zotarolumus-eluting stent, optical coherence tomography

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

DM, angio group

DM, OCT group

non DM, angio group

non DM, OCT group

Arm Description

Outcomes

Primary Outcome Measures

ratio of the stent strut

Secondary Outcome Measures

Full Information

First Posted
May 31, 2013
Last Updated
June 4, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01869842
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Stable Angina, Unstable Angina
Keywords
Resolute zotarolumus-eluting stent, optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DM, angio group
Arm Type
Active Comparator
Arm Title
DM, OCT group
Arm Type
Experimental
Arm Title
non DM, angio group
Arm Type
Active Comparator
Arm Title
non DM, OCT group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention
Intervention Description
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
Intervention Type
Procedure
Intervention Name(s)
OCT-guided percutaneous coronary intervention
Intervention Description
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention
Intervention Description
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
Intervention Type
Procedure
Intervention Name(s)
OCT-guided percutaneous coronary intervention
Intervention Description
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
Primary Outcome Measure Information:
Title
ratio of the stent strut
Time Frame
Angiographic follow-up with OCT at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myeong Ki Hong, Md, PhD
Phone
82-2-2228-8460
Email
mkhong61@yuhs.ac
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MyeongKi Hong, MD, PhD
Phone
82-2-2228-8460
Email
mkhong61@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Myeong Ki Hong, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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