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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01869842
• Other study ID #: 1-2011-0070
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2013
• Last updated: June 4, 2013
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: May 2013
• Source: Yonsei University
• Contact: Myeong Ki Hong, Md, PhD
• Phone: 82-2-2228-8460
• Email: mkhong61[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina
• Unstable Angina

Intervention

Procedure:
• percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
• OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
• percutaneous coronary intervention
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
• OCT-guided percutaneous coronary intervention
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	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	ratio of the stent strut		Angiographic follow-up with OCT at 6 months	No