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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019869
Receipt No. R000022958
Scientific Title Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents
Date of disclosure of the study information 2015/11/20
Last modified on 2015/11/20

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Basic information
Public title Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents
Acronym Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents
Scientific Title Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents
Scientific Title:Acronym Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents
Region
Japan

Condition
Condition cryptogenic stroke
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of transcatheter PFO closure in patients with cryptogenic stroke
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes procedure success rate
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Transcatheter PFO closure
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
70 years-old >
Gender Male and Female
Key inclusion criteria cryptogenic stroke
Key exclusion criteria other stroke
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Teiji Akagi
Organization Okayama University Hospital
Division name cardiac intensive care unit
Zip code
Address Okayama city
TEL 086-235-7151
Email t-akagi@cc.okayama-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Teiji Akagi
Organization none
Division name none
Zip code
Address none
TEL 086-223-7151
Homepage URL
Email t-akagi@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None
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
Email

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
2015 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Catheter closure of a patent foramen ovale could be safely performed with Ampatzer Cribriform or Amplatzer PFO Occluder. This procedure may contribute to prevention of recurrent cryptogenic CVA in Japanese patients, especially in patients who have spontaneous interatrial right-to-left shunts.
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 Main results already published
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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
2015 Year 11 Month 20 Day
Last modified on
2015 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022958

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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