UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056909 |
|---|---|
| Receipt number | R000061619 |
| Scientific Title | ClotTriever Thrombectomy System Use-result Survey |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2025/09/29 15:09:32 |
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Basic information
Public title
ClotTriever Thrombectomy System Use-result Survey
Acronym
ClotTriever Thrombectomy System Use-result Survey
Scientific Title
ClotTriever Thrombectomy System Use-result Survey
Scientific Title:Acronym
ClotTriever Thrombectomy System Use-result Survey
Region
| Japan |
Condition
Condition
Patients with deep vein thrombosis with acute severe symptoms (excluding post thrombotic syndrome)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this survey is to determine the safety and efficacy of the ClotTriever Thrombectomy System under daily clinical practice after marketing approval in Japan.
This device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Rate of Major Adverse Events [MAEs: All-cause mortality, Major bleeding, New symptomatic Pulmonary Embolism (PE) documented by Computed Tomography Pulmonary Angiography (CTPA), Rethrombosis of a Target Venous Segment] through 30 days after the index procedure.
-Technical success (thrombus residual volume is assessed by the sites using pre- and post-procedure venography to evaluate the success of thrombus removal)
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
All patients treated with this device
Key exclusion criteria
N/A
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ichinose |
Organization
Vorpal Technologies K.K
Division name
Regulatory Affairs
Zip code
161-0034
Address
Oval Shinjuku Building, 3-10-8 Kami-Ochiai, Shinjuku-ku, Tokyo
TEL
+81-3-5544-8340
Hiroshi.Ichinose@mcra.com
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Inoue |
Organization
Vorpal Technologies K.K
Division name
Regulatory Affairs
Zip code
161-0034
Address
Oval Shinjuku Building, 3-10-8 Kami-Ochiai, Shinjuku-ku, Tokyo
TEL
+81-3-5544-8340
Homepage URL
Satoko.Inoue@mcra.com
Sponsor or person
Institute
Vorpal Technologies K.K
Institute
Department
Personal name
Funding Source
Organization
Inari Medical Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2025 | Year | 02 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since this is a use-resut survey, no IRB review.
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061619
