UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015157 |
|---|---|
| Receipt number | R000017628 |
| Scientific Title | Early vessel healing after implantation of a hydrophilicpolymer-coated Zotarolimus-eluting stent. Serial Optical Coherence Tomography study. |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2014/09/14 19:01:38 |
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Basic information
Public title
Early vessel healing after implantation of
a hydrophilicpolymer-coated Zotarolimus-eluting stent.
Serial Optical Coherence Tomography study.
Acronym
Early vessel healing after implantation of
a hydrophilicpolymer-coated Zotarolimus-eluting stent.
Serial Optical Coherence Tomography study.
Scientific Title
Early vessel healing after implantation of
a hydrophilicpolymer-coated Zotarolimus-eluting stent.
Serial Optical Coherence Tomography study.
Scientific Title:Acronym
Early vessel healing after implantation of
a hydrophilicpolymer-coated Zotarolimus-eluting stent.
Serial Optical Coherence Tomography study.
Region
| Japan |
Condition
Condition
Angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early stage safety and efficicacy after implantation of Zotarolimus-eluting stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Stent coverage after a month
Key secondary outcomes
Comparison of IVUS guided PCI and OCT guided PCI in stent coverage after a month
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Implantaion of Zotarolimus-eluting stent
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Angina patient with ischemic symptoms
(2)De novo lesions with >50% diameter stenosis by coronary angiography which native vessel size of 2.25 to 3.5 mm
(3)Patients who agreed with this study
Key exclusion criteria
(1)unprotected left main coronary artery disease
(2)overlapping stent or bifurcation lesions requiring 2 stents
(3)renal insufficiency with baseline creatinine >2.0 mg/dl
(4)life expectancy <1 year
(5)lesions with anatomy unsuitable for OCT imaging
(6)patient with cardiogenic shock
(7)pregnant patient
(8)a plan for elective surgery within 6 months
9) known intol-erance to a study drug, metal alloys, or contrast media etc
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TEPPEI NODA |
Organization
Kansai Medical University
Division name
The second department of internal medicine
Zip code
Address
10-15 Fumizono-cho,Moriguchi-shi,Osaka,Japan
TEL
06-6992-1001
kmucirnt@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TEPPEI NODA |
Organization
Kansai Medical University
Division name
The second department of internal medicine
Zip code
Address
10-15 Fumizono-cho,Moriguchi-shi,Osaka,Japan
TEL
+81669921001
Homepage URL
kmucirnt@gmail.com
Sponsor or person
Institute
Kansai Medical University
The second department of internal medicine
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
The second department of internal medicine
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
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
| 2014 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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
Management information
Registered date
| 2014 | Year | 09 | Month | 14 | Day |
Last modified on
| 2014 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017628
