Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan) (TRON1-Japan)

July 17, 2019 updated by: JIMRO Co., Ltd.

A Multicenter, Single-arm Study of the Efficacy and Safety of a Thrombectomy Device (T-01) for the Treatment of Acute Cerebral Infarction

To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction (within 8 hours after onset), in whom intravenous administration of tissue plasminogen activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA administration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu, Japan
        • Gifu University Hospital
      • Kyoto, Japan
        • Japanese Red Cross Kyoto Daiichi Hospital
      • Nagasaki, Japan
        • Nagasaki University Hospital
      • Wakayama, Japan
        • Wakayama Medical University Hospital
      • Yamagata, Japan
        • Yamagata City Hospital Saiseikan
    • Fukuoka
      • Kurume, Fukuoka, Japan
        • Kurume University Hospital
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Brain Attack Center Ota Memorial Hospital
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City Medical Center General Hospital
      • Nishinomiya, Hyogo, Japan
        • Hyogo College of Medicine
    • Ibaraki
      • Tsukuba, Ibaraki, Japan
        • University of Tsukuba Hospital
    • Mie
      • Ise, Mie, Japan
        • Ise Red Cross Hospital
    • Miyagi
      • Sendai, Miyagi, Japan
        • Kohnan Hospital
    • Osaka
      • Suita, Osaka, Japan
        • National Cerebral and Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with neurological disorders caused by blood vessel occlusion associated with acute cerebral infarction
  2. Patients who can receive treatment within 8 hours after onset of symptoms of acute cerebral infarction
  3. Patients in whom intravenous administration of t-PA is not indicated or reperfusion cannot be achieved by intravenous t-PA administration
  4. Patients who have accessible occlusion of the middle cerebral artery (M1 or M2 to 3), basilar artery, vertebral artery, posterior cerebral artery (P1 or P2), anterior cerebral artery (A1 to 2), or intracranial internal carotid artery (pre-procedure TICI score, 0 or 1) as determined by angiography
  5. Patients with an NIHSS score of 8 to 30
  6. Patients with an mRS score of 0 to 2 before onset
  7. Patients aged between 20 and 85 years (at the time of informed consent)
  8. Patients who are able to provide written consent (signature) or whose legally acceptable representative (a person with parental authority, spouse, guardian, and an individual legally responsible for his/her custody) can provide written consent (signature)

Exclusion Criteria:

  1. Patients who manifest the following:

    • Carotid artery dissection
    • Vasculitis
    • An angulated vessel, making it difficult to guide an investigational device
    • Significant (>50%) stenosis, making it difficult to guide an investigational device
    • Acute intracranial hemorrhage
    • Mass lesion or intracranial tumor
    • Widespread early ischemic changes revealed by CT or MRI
  2. Patients who have two or more different major cerebrovascular occlusions requiring treatment
  3. Patients with an allergy to contrast agents or who cannot receive them or those who have a serious metal allergy
  4. Patients who received heparin within 48 hours and have Partial Thromboplastin Time (PTT)/Activated Partial Thromboplastin Time (APTT) > twice the upper limit of normal
  5. Patients with known bleeding tendencies or coagulation deficiency or who have received oral anticoagulants (such as warfarin), and who have (PT-) International Normalized Ratio (INR) >3
  6. Patients with platelet count <30,000 /mm3
  7. Patients with blood glucose levels <50 mg/dL
  8. Patients with uncontrolled hypertension (systolic BP >185 mmHg and diastolic BP >110 mmHg)
  9. Patients with expected life expectancy <90 days
  10. Female patients who are pregnant or breast feeding
  11. Patients who are participating in clinical trials of drugs or medical devices
  12. Patients disqualified from participation in the study by the investigator (sub-investigator) due to reasons other than the above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Thrombectomy Device(T-01)
Mechanical Thrombectomy with T-01
Device: Thrombectomy Device T-01

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary efficacy endpoint of the study is rate of immediate post-procedure reperfusion with the device in 2 pathways/device or 3 pathways/vessel measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2a or greater.
Time Frame: immediate post procedure
immediate post procedure
The primary safety endpoint of the study is mortality within 90 days after the procedure
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
Time Frame: immediate post-procedure
immediate post-procedure
Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure
Time Frame: 24 hours
24 hours
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or greater whose National Institute of Health Stroke Scale (NIHSS) score improved by 10 points or more from baseline at 90 days post-procedure
Time Frame: 90 days
90 days
Assessment of mRS scores at 90 days post-procedure
Time Frame: 90 days
90 days
Assessment of NIHSS scores at 90 days post-procedure
Time Frame: 90 days
90 days
Assessment of Barthel Index (BI) scores at 90 days post-procedure
Time Frame: 90 days
90 days
Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure
Time Frame: 24 hours
24 hours
Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure
Time Frame: 24 hours
24 hours
Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure
Time Frame: 24 hours
24 hours
Incidence of device- or procedure-related serious adverse events within 90 days after the procedure
Time Frame: 90 days
90 days
Number of any defect in the investigational device
Time Frame: at the time of inspection before procedure, intraoperative and immediate post-procedure
at the time of inspection before procedure, intraoperative and immediate post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JIMRO Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nobuyuki Sakai, M.D., D.M. Sc, Kobe City Medical Center General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BJSTO-16-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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