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)
Phase 4
Recruiting
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Registration Number
- JPRN-UMIN000011898
- Lead Sponsor
- Division of Cardiovascular Medicine, National Hospital Organization Okayama Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
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 ≥ 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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method