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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01869842

Enrollment

115

Registered

2013-06-05

Start date

2011-12-31

Completion date

2016-12-31

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Stable Angina, Unstable Angina

Keywords

Resolute zotarolumus-eluting stent, optical coherence tomography

Brief 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.

Interventions

PROCEDUREpercutaneous coronary intervention

the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion

PROCEDUREOCT-guided percutaneous coronary intervention

the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ratio of the stent strut	Angiographic follow-up with OCT at 6 months

Countries

South Korea

Contacts

Primary ContactMyeong Ki Hong, Md, PhD

mkhong61@yuhs.ac82-2-2228-8460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026