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Completed

NCT Number: NCT01752894

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(EES) Versus Biolimus A9-eluting Stents(BES)

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 vs BES implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 aorta-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)
  • 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

Treatment and study plan

Angio-guided PCI with EES or BES

Device

Angio-guided intervention

OCT-guided PCI with EES or BES

Device

OCT-guided intervention

PCI with BES under angio-guide or OCT guide

Device

biolimus A9-eluting stent.

PCI with EES under angio-guide or OCT guide

Device

everolimus eluting stent.

Keep DAPT

Drug

maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.

Discontinue DAPT

Drug

discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.

Primary outcomes

  1. percentage of neointimal coverage at 3 month-OCT after stent implantation

    Time frame: at 3 month-OCT after stent implantation

Secondary outcomes

  1. The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months

    Time frame: 12 months after PCI

  2. percentage of malposition strut at 3 month-OCT after stent implantation

    Time frame: 3 months after PCI

  3. The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.

    Time frame: 12 months after PCI

  4. Target vessel revascularization

    Time frame: 12 months after PCI

  5. TIMI-defined major bleeding for 12 months

    Time frame: 12 months after PCI

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: DETECT-OCT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2012
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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