UMIN-CTR Clinical Trial

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 Development Department 4
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043236