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)

Ischemic Heart Disease Clinical Trial

— DETECT-OCT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752894
• Other study ID #: 1-2012-0047
• Status: Completed
• Phase: N/A
• Start date: January 2, 2013
• Est. completion date: April 11, 2017

Study information

• Verified date: March 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 776
• Est. completion date: April 11, 2017
• Est. primary completion date: April 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Angio-guided PCI with EES or BES
Angio-guided intervention
• OCT-guided PCI with EES or BES
OCT-guided intervention
• PCI with BES under angio-guide or OCT guide
biolimus A9-eluting stent.
• PCI with EES under angio-guide or OCT guide
everolimus eluting stent.

Drug:
• Keep DAPT
maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.
• Discontinue DAPT
discontinue DAPT according to level of uncovered strut (=6%) at 3months OCT follow up after stent implantation.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of neointimal coverage at 3 month-OCT after stent implantation		at 3 month-OCT after stent implantation
Secondary	The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months		12 months after PCI
Secondary	percentage of malposition strut at 3 month-OCT after stent implantation		3 months after PCI
Secondary	The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.		12 months after PCI
Secondary	Target vessel revascularization		12 months after PCI
Secondary	TIMI-defined major bleeding for 12 months		12 months after PCI