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

Yonsei University

Status: Unknown

Conditions: Coronary Artery Disease; Unstable Angina; Stable Angina

Treatments: Procedure: percutaneous coronary intervention; Procedure: OCT-guided percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01869842

1-2011-0070

Details and patient eligibility

About

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.

Enrollment: 115 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 4 patient groups

DM, angio group

Active Comparator group

Treatment:

Procedure: percutaneous coronary intervention

Procedure: percutaneous coronary intervention

DM, OCT group

Experimental group

Treatment:

Procedure: OCT-guided percutaneous coronary intervention

Procedure: OCT-guided percutaneous coronary intervention

non DM, angio group

Active Comparator group

Treatment:

Procedure: percutaneous coronary intervention

Procedure: percutaneous coronary intervention

non DM, OCT group

Experimental group

Treatment:

Procedure: OCT-guided percutaneous coronary intervention

Procedure: OCT-guided percutaneous coronary intervention