UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033777 |
|---|---|
| Receipt number | R000038528 |
| Scientific Title | Effects of Bioabsorbable Polymer Drug-Eluting Stents (DES) on Coronary Hyperconstricting Responses After Percutaneous Coronary Intervention in Comparison with Durable Polymer DES - A Randomized Controlled Study - |
| Date of disclosure of the study information | 2018/08/16 |
| Last modified on | 2021/02/16 13:56:26 |
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Basic information
Public title
Effects of Bioabsorbable Polymer Drug-Eluting Stents (DES) on Coronary Hyperconstricting Responses After Percutaneous Coronary Intervention in Comparison with Durable Polymer DES - A Randomized Controlled Study -
Acronym
Effects of Bioabsorbable Polymer Drug-Eluting Stents (DES) on Coronary Hyperconstricting Responses After Percutaneous Coronary Intervention in Comparison with Durable Polymer DES - A Randomized Controlled Study -
Scientific Title
Effects of Bioabsorbable Polymer Drug-Eluting Stents (DES) on Coronary Hyperconstricting Responses After Percutaneous Coronary Intervention in Comparison with Durable Polymer DES - A Randomized Controlled Study -
Scientific Title:Acronym
Effects of Bioabsorbable Polymer Drug-Eluting Stents (DES) on Coronary Hyperconstricting Responses After Percutaneous Coronary Intervention in Comparison with Durable Polymer DES - A Randomized Controlled Study -
Region
| Japan |
Condition
Condition
Ischemic cardio myopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of bioabsorbable polymer drug-eluting Stents (DES) on coronary hyperconstricting responses after percutaneous coronary intervention in comparison with durable polymer DES
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of bioabsorbable polymer drug-eluting stents (DES) on coronary hyperconstricting responses after percutaneous coronary intervention in comparison with durable polymer DES
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Bioabsorbable polymer Drug-Eluting Stents
Interventions/Control_2
Durable polymer DES
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
Ischemic cardio myopathy
Key exclusion criteria
(1)Acute coronary syndrome
(2)EF is under 40%
(3)Chronic Total Occlusion
(4)Severe hepatic and renal failure
(5)Severe acetylcholine allergy
(6)Severe contrast allergy
(7)asthma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL
+81-22-717-7153
shimo@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Matsumoto |
Organization
Tohoku University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL
+81-22-717-7153
Homepage URL
matsumoto@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for promotion science
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2018 | Year | 08 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038528
