UMIN-CTR Clinical Trial

Basic information
Public title	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) -
Acronym	RI-ZES OCT Study
Scientific Title	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) -
Scientific Title:Acronym	RI-ZES OCT Study
Region	Japan

Condition
Condition	Ischemic Heart Disease, Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate a possible reduction in the duration of post-procedural double antiplatelet therapy through observation of morphological changes in neointima at the site of stenting with the use of OCT at 1- and 9-month after Resolute Integrity zotarolimus-eluting stent implantation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	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)
Key secondary outcomes

Base
Study type	Observational

Study design
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Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitusru Munemasa
Organization	National Hospital Organization Okayama Medical Center
Division name	Division of Cardiovascular Medicine
Zip code
Address	1711-1 Tamasu, Kita-ku, Okayama 701-1192, Japan
TEL	+81862949911
Email	munemasa@okayama3.hosp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Mitusru Munemasa
Organization	National Hospital Organization Okayama Medical Center
Division name	Division of Cardiovascular Medicine
Zip code
Address	1711-1 Tamasu, Kuta-ku, Okayama 701-1192, Japan
TEL	+81862949911
Homepage URL
Email	munemasa@okayama3.hosp.go.jp

Sponsor
Institute	Division of Cardiovascular Medicine, National Hospital Organization Okayama Medical Center
Institute
Department

Funding Source
Organization	None
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Division
Category of Funding Organization	Other
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Other related organizations
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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 08 Month 01 Day
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Other
Other related information	OCT imaging analysis: A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15 frames) over the entire stent length at 1 and 9 months after stenting.

Management information
Registered date	2013 Year 09 Month 27 Day
Last modified on	2013 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013901

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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