DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents; DETECT-OCT Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01752894
First received: December 14, 2012
Last updated: July 20, 2014
Last verified: February 2014
  Purpose

The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES (Xience Prime®) vs N-BES (Nobori®) implantation, and 3> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months.


Condition Intervention
Ischemic Heart Disease
Device: Angio-guided intervention
Device: OCT-guided intervention
Device: PCI with N-BES (Nobori®) under angio-guide or OCT guide
Device: PCI with EES (Xience Prime®) under angio-guide or OCT guide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Percentage of uncovered stent strut [ Time Frame: at 3 month-OCT after stent implantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: January 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Angio-guided PCI
Angio-guided PCI
Device: Angio-guided intervention
Experimental: OCT-guided PCI
OCT-guided PCI
Device: OCT-guided intervention
Active Comparator: N-BES (Nobori®)
N-BES (Nobori®)
Device: PCI with N-BES (Nobori®) under angio-guide or OCT guide
Experimental: EES (Xience Prime®)
EES (Xience Prime®)
Device: PCI with EES (Xience Prime®) under angio-guide or OCT guide

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 20 years old
  • Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation.
  • Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

  • Complex lesion morphologies such as arota-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
  • Reference vessel diameter < 2.5 mm or > 4.0mm
  • Heavy calcified lesions (definite calcified lesions on angiogram)
  • Lesions requiring 2 or more DES
  • Primary PCI for STEMI
  • 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)
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752894

Contacts
Contact: MYEONG-KI HONG, MD 82-2-2228-8458 MKHONG61@yuhs.ac

Locations
Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: MYEONG-KI HONG, MD    82-2-2228-8458    MKHONG61@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01752894     History of Changes
Other Study ID Numbers: 1-2012-0047
Study First Received: December 14, 2012
Last Updated: July 20, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014