UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043488 |
|---|---|
| Receipt number | R000049658 |
| Scientific Title | Feasibility of coronary access and re-intervention after transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2021/03/02 |
| Last modified on | 2024/03/03 16:22:00 |
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Basic information
Public title
Feasibility of coronary access and re-intervention after transcatheter aortic valve implantation
Acronym
Feasibility of coronary access and re-intervention after transcatheter aortic valve implantation
Scientific Title
Feasibility of coronary access and re-intervention after transcatheter aortic valve implantation
Scientific Title:Acronym
Feasibility of coronary access and re-intervention after transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of coronary access and re-intervention after transcatheter aortic valve implantation using a multidetector computed tomography
Basic objectives2
Others
Basic objectives -Others
To assess the feasibility of coronary access and re-intervention after transcatheter aortic valve implantation using a multidetector computed tomography
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) feasibility of coronary access
2) feasibility of re-intervention
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
Patients undergoing TAVI for native aortic stenosis from March 2021 in Sakakibara Heart Institute.
Key exclusion criteria
death, no consent, debilitated condition, allergy of contrast media, renal dysfunction (eGFR<45)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Higuchi |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
183-0003
Address
Asahicho 3-16-1, Fuchu, Tokyo, Japan
TEL
042-314-3111
rhiguchi@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Higuchi |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
183-0003
Address
Asahicho3-16-1, Fuchu, Tokyo, Japan
TEL
042-314-3111
Homepage URL
rhiguchi@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Sakakibara Heart Institute
Address
Asahicho3-16-1, Fuchu, Tokyo, Japan
Tel
042-314-3111
rhiguchi@shi.heart.or.jp
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
| 2021 | Year | 03 | Month | 02 | 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
| 2021 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
analysis of CT findings
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049658
