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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043747
Receipt No. R000049942
Scientific Title Angioscopic evaluation for device neo-endothlialization and the residual shunt of patent foramen ovale closure device 12-months after implantation
Date of disclosure of the study information 2021/03/26
Last modified on 2021/09/29

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Basic information
Public title Angioscopic evaluation for device neo-endothlialization and the residual shunt of patent foramen ovale closure device 12-months after implantation
Acronym Angioscopic evaluation of patent foramen ovale closure device neo-endothelialization
Scientific Title Angioscopic evaluation for device neo-endothlialization and the residual shunt of patent foramen ovale closure device 12-months after implantation
Scientific Title:Acronym Angioscopic evaluation of patent foramen ovale closure device neo-endothelialization
Region
Japan

Condition
Condition patent foramen ovale
Classification by specialty
Cardiology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the neo-endothelialization and the residual shunt of the patent foramen ovale closure device at 12-months after implantation
Basic objectives2 Others
Basic objectives -Others To suggest the optimal antithrombotic therapy after trans-catheter closure for patent foramen ovale
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Device neo-endothelialization and the residual shunt at 12-months after implantation
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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent the trasns-catheter closure for the patent foramen ovale at St. Marianna University School of Medicine Hospital
Key exclusion criteria Patients who do not agree with the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Tanabe
Organization St. Marianna University School of Medicine
Division name Division of Cardiology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
TEL +81-044-977-8111
Email y-tanabe@muj.biglobe.ne.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Tanabe
Organization St. Marianna University School of Medicine
Division name Division of Cardiology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
TEL +81-44-977-8111
Homepage URL
Email y-tanabe@muj.biglobe.ne.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Abott Vascular Japan, Co.Ltd
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 IRB of St. Marianna University School of Medicine
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
Tel +81-44-977-8111
Email k-sienbu.mail@marianna-u.ac.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 26 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 15 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will assess the neo-endothelialization of the PFO closure device by angioscopy and residual shunt by the micro bubble test of trans esophageal ultrasound at 12-months after the implantation.

Management information
Registered date
2021 Year 03 Month 25 Day
Last modified on
2021 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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