Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) -

Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) - - RI-ZES OCT Study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011898

Enrollment

Registered

2013-10-01

Start date

2013-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Ischemic Heart Disease, Coronary Artery Disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study will enroll patients who are eligible for treatment with drug-eluting stents and who are scheduled for staged PCI. The Resolute Integrity stent will be implanted in lesions responsible for index PCI in 50 patients scheduled for staged PCI. This clinical study will be conducted with minimal exclusion criteria to reflect real-world clinical practice in the study.

Exclusion criteria

Exclusion criteria: - Unprotected LMT lesions - Patients with cardiogenic shock - Patients who have decompensated hypotension or are intubated, and those with cardiac failure requiring IABP - Patients treated with debulking, such as Rotablator and DCA - Patients with renal impairment (Cre &#8805; 1.5) - Proximal lesions within 10 mm from the coronary ostia (OCT not available) - Patients from whom no written consent is obtained - Other patients considered ineligible for this clinical study by the investigator

Design outcomes

Primary

Measure	Time frame
A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15frames) over the entire stent length at 1 and 9 months after stenting. [Qualitative analysis] - Number of stent struts analyzed - Neointimal coverage (neointimal coverage in stent struts) - Stent incomplete apposition (post-procedural incomplete stent apposition) - Prolapse (plaque prolapse) - Thrombus (thrombus around stent struts) - Dissection (coronary dissection) [Quantitative analysis] - Neointimal thickness (NIT)	—

Measure

Time frame

A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15frames) over the entire stent length at 1 and 9 months after stenting. [Qualitative analysis] - Number of stent struts analyzed - Neointimal coverage (neointimal coverage in stent struts) - Stent incomplete apposition (post-procedural incomplete stent apposition) - Prolapse (plaque prolapse) - Thrombus (thrombus around stent struts) - Dissection (coronary dissection) [Quantitative analysis] - Neointimal thickness (NIT)

—

Countries

Japan

Contacts

Public ContactMitusru Munemasa

National Hospital Organization Okayama Medical Center Division of Cardiovascular Medicine

munemasa@okayama3.hosp.go.jp+81862949911

Outcome results