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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038026
Receipt No. R000043236
Scientific Title Japan Trevo Registry
Date of disclosure of the study information 2019/10/01
Last modified on 2021/06/02

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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
Email TrevoRegistry@a2healthcare.com

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Konuki
Organization A2 Healthcare Corporation
Division name Clinical Research Department
Zip code 112-0002
Address 1-4-1,Koishikawa,Bunkyo-Ku,Tokyo,Japan
TEL 03-3830-1074
Homepage URL
Email TrevoRegistry@a2healthcare.com

Sponsor
Institute Stryker Japan K.K.
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043236

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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