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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011898
Receipt No. R000013901
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) -
Date of disclosure of the study information 2013/10/01
Last modified on 2013/09/27

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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
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

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
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
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
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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