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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 not yet open for participant recruitment.
Verified December 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01752894
First received: December 14, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Neointimal coverage [ Time Frame: at 3 month-OCT after stent implantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1100
Study Start Date: January 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (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
No Contacts or Locations Provided
  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: December 14, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 19, 2013