UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021122 |
|---|---|
| Receipt number | R000015092 |
| Scientific Title | Study examining the PROMUS Element everolimus-eluting stent in multi-center Coronary Intervention of complex Arterial Lesion Subsets (OCT and IVUS sub analysis) |
| Date of disclosure of the study information | 2016/02/21 |
| Last modified on | 2016/02/21 10:36:49 |
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Basic information
Public title
Study examining the PROMUS Element everolimus-eluting stent in multi-center Coronary Intervention of complex
Arterial Lesion Subsets (OCT and IVUS sub analysis)
Acronym
SPECIALIST registry
Scientific Title
Study examining the PROMUS Element everolimus-eluting stent in multi-center Coronary Intervention of complex
Arterial Lesion Subsets (OCT and IVUS sub analysis)
Scientific Title:Acronym
SPECIALIST registry
Region
| Japan |
Condition
Condition
Complex coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to evaluating the safety and efficacy of third generation DES in the treatment of complex lesions, this study will also examine, using IVUS and OCT, diabetic patients' plaque characteristics as well as stent expandability during placement in these lesions, and finally long term healing response and thrombus formation in the diabetic patient cohort.Additionally, the cause effect relationship between these elements and secondary cardiovascular event occurrence will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
% stent struts uncovered at 9 month as measured by OCT
Key secondary outcomes
% stent struts uncovered at 24 month as measured by OCT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Platinum chromium everolimus-eluting stent (PtCr-EES) (manufactured as PROMUS Element by Boston Scientific)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Ischemic heart disease including stable angina pectoris and acute coronary syndrome
b. Male or non-pregnant female
c. Key lesion inclusion criteria as follows
(1) Multi-vessel diseases
(2) Long lesion (lesion length >30mm by visual estimation)
(3) Small vessel disease (reference diameter <2.5mm by visual estimation)
(4) Bifurcation lesion
(5) Calcified lesion
(6) Protected or non-protected left main trunk disease
Key exclusion criteria
(1) Chronic total occlusion
(2) In stent restenosis of bare metal stent or everolimus-eluting stent
(3) Ostial lesion
(4)Excessive tortuosity proximal to or within the lesion
(5)Extreme angulation proximal to or within the lesion
(6)Lesion is not an acceptable candidate for Optical Coherence Tomography
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Oikawa, Kenya Nasu |
Organization
The Cardiovascular Institute,Toyohashi Heart Center
Division name
Cardiology
Zip code
Address
21-1 O-yama cho, Toyohashi, Aichi, 4418530, Japan
TEL
0532-37-3377
yuyatomoya@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiology
Zip code
Address
21-1 O-yama cho, Toyohashi, Aichi, 4418530, Japan
TEL
0532-37-3377
Homepage URL
yuyatomoya@gmail.com
Sponsor or person
Institute
The PCI Guideline Research Society
Institute
Department
Personal name
Funding Source
Organization
The PCI Guideline Research Society
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 21 | Day |
Last modified on
| 2016 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015092
