UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038026 |
|---|---|
| Receipt number | R000043236 |
| Scientific Title | Japan Trevo Registry |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/04/01 16:22:47 |
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Basic information
Public title
Japan Trevo Registry
Acronym
Japan Trevo Registry
Scientific Title
Japan Trevo Registry
Scientific Title:Acronym
Japan Trevo Registry
Region
| Japan |
Condition
Condition
Acute ischemic stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Information on patients treated with Trevo Pro Clot Retriever in Japan will be collected and its efficacy and safety in routine clinical practice will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Effective blood flow reperfusion rate at the end of the whole procedure (defined as mTICI >= 2b)
Key secondary outcomes
Efficacy
Degree of independence in daily living 90 days after the procedure (defined as mRS <= 2)
Safety
- Rate of worsening of neurological symptoms within 24 hours after the procedure (defined as exacerbation of NIHSS >= 4)
- Incidence of symptomatic intracranial bleeding within 24 hours after the procedure
- All-cause mortality within 90 days after the procedure
- Incidence of adverse events related to the Trevo Retriever
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged >= 20 years
2. Patients treated with Trevo Retriever as a thrombectomy device in first-line treatment
- Those with first pass using the Trevo Retriever alone or in combination with an aspiration catheter
- Excluding those with first pass using another thrombectomy device (stent retriever/aspiration catheter)
- A PTA balloon is not considered a thrombectomy device.
3. Patients who gave informed consent or whose legally acceptable representative gave informed consent
4. Patients expected to be evaluable for the 90-day observation period after the procedure
Key exclusion criteria
Patients treated with a medical device that is unapproved in Japan
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Hyogo College of Medicine
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1,Mukogawa-cyou,Nishiomiya-city,Hyougo
TEL
03-3830-1074
TrevoRegistry@a2healthcare.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Konuki |
Organization
A2 Healthcare Corporation
Division name
Clinical Development Department 4
Zip code
112-0002
Address
1-4-1,Koishikawa,Bunkyo-Ku,Tokyo,Japan
TEL
03-3830-1074
Homepage URL
TrevoRegistry@a2healthcare.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
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
Hyogo College of Medicine
Address
1-1,Mukogawa-cyou,Nishiomiya-city,Hyougo
Tel
03-3830-1074
TrevoRegistry@a2healthcare.com
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
| 2019 | Year | 10 | Month | 01 | 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
1026
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
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The information will be collected within normal clinical practice for each patient.
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043236
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
