UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008728 |
|---|---|
| Receipt number | R000010256 |
| Scientific Title | Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I) |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2015/07/16 13:24:17 |
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Basic information
Public title
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I)
Acronym
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I)
Scientific Title
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I)
Scientific Title:Acronym
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I)
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Patients with undergoing percutaneous interventional cardiac procedures for treatment of coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to collect data to identify an OCT peri-procedural guidance parameter(s) for stenting that relates with patient outcomes in the hospital, at 30 days, and 12 months post intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The number and rate of subjects who have any reported MACE at each interval
2.Individual components of MACE at each interval
3.Descriptive statistics on OCT pre and post intervention measurements
4.Relationship between OCT peri-procedural measurements and MACE and each individual components of MACE
Key secondary outcomes
1.Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment
2.OCT parameters as assessed by Core Lab
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age >= 18 years.
2.Patient provides signed written informed consent before any study-specific procedure.
3.De novo coronary artery disease in target vessel.
4.Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
5.Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).
6.Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.
7.Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR <= 0.80 in target vessel.
Key exclusion criteria
1.Subjects with STEMI, emergent PCI, or in cardiogenic shock.
2.Subjects with target left main lesion.
3.Subjects with restenosis or stent thrombosis in the target vessel.
4.Planned use of bare metal stent.
5.Known renal insufficiency (examples being but not limited to eGFR < 60 ml/kg/m2, serum creatinine >= 2.5 mg/dL, or on dialysis).
6.Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
7.Extreme angulation (> 90 degree) or excessive tortuosity (> two 45 degree angles) proximal to or within the target lesion.
8.Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
9.Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
10.Currently participating in another clinical study that interferes with study results.
11.Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
12.Life expectancy less than 1 year.
13.Potential for non-compliance to protocol requirements and follow-up.
14.Planned or prior heart transplantation or listed for heart transplant.
15.Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akasaka |
Organization
Wakayama Medicai University Hospital
Division name
Division of Cardiology
Zip code
Address
811-1 Kimiidera, Wakayama City, Wakayama, 641-8509, Japan,
TEL
03-6255-5720
YMasui@sjm.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuri Masui |
Organization
St. Jude Medical Japan Co., Ltd.
Division name
Clinical Affairs
Zip code
Address
Hamarikyu Park Site Place 9F 5-6-10, Tsukiji, Chuo-ku, Tokyo
TEL
03-3524-1792
Homepage URL
YMasui@sjm.com
Sponsor or person
Institute
St. Jude Medical Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
St. Jude Medical Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01663896
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学附属病院（和歌山県）
神戸大学医学部附属病院（兵庫県）
大阪府済生会中津病院（大阪府）
奈良県立医科大学附属病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 08 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 27 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Prospective, multicenter study
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2015 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010256
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| Registered date | File name |
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