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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Thrombectomy Device T-01
Sponsored by
JIMRO Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kurume University Hospital
  • Brain Attack Center Ota Memorial Hospital
  • Kobe City Medical Center General Hospital
  • Hyogo College of Medicine
  • University of Tsukuba Hospital
  • Ise Red Cross Hospital
  • Kohnan Hospital
  • National Cerebral and Cardiovascular Center
  • Gifu University Hospital
  • Japanese Red Cross Kyoto Daiichi Hospital
  • Nagasaki University Hospital
  • Wakayama Medical University Hospital
  • Yamagata City Hospital SAISEIKAN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thrombectomy Device(T-01)

Arm Description

Mechanical Thrombectomy with T-01

Outcomes

Primary Outcome Measures

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.
The primary safety endpoint of the study is mortality within 90 days after the procedure

Secondary Outcome Measures

Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure
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
Assessment of mRS scores at 90 days post-procedure
Assessment of NIHSS scores at 90 days post-procedure
Assessment of Barthel Index (BI) scores at 90 days post-procedure
Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure
Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure
Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure
Incidence of device- or procedure-related serious adverse events within 90 days after the procedure
Number of any defect in the investigational device

Full Information

First Posted
November 9, 2016
Last Updated
July 17, 2019
Sponsor
JIMRO Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02964702
Brief Title
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)
Acronym
TRON1-Japan
Official Title
A Multicenter, Single-arm Study of the Efficacy and Safety of a Thrombectomy Device (T-01) for the Treatment of Acute Cerebral Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JIMRO Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrombectomy Device(T-01)
Arm Type
Experimental
Arm Description
Mechanical Thrombectomy with T-01
Intervention Type
Device
Intervention Name(s)
Thrombectomy Device T-01
Primary Outcome Measure Information:
Title
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
Title
The primary safety endpoint of the study is mortality within 90 days after the procedure
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
Time Frame
immediate post-procedure
Title
Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure
Time Frame
24 hours
Title
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
Title
Assessment of mRS scores at 90 days post-procedure
Time Frame
90 days
Title
Assessment of NIHSS scores at 90 days post-procedure
Time Frame
90 days
Title
Assessment of Barthel Index (BI) scores at 90 days post-procedure
Time Frame
90 days
Title
Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure
Time Frame
24 hours
Title
Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure
Time Frame
24 hours
Title
Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure
Time Frame
24 hours
Title
Incidence of device- or procedure-related serious adverse events within 90 days after the procedure
Time Frame
90 days
Title
Number of any defect in the investigational device
Time Frame
at the time of inspection before procedure, intraoperative and immediate post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with neurological disorders caused by blood vessel occlusion associated with acute cerebral infarction Patients who can receive treatment within 8 hours after onset of symptoms of acute cerebral infarction Patients in whom intravenous administration of t-PA is not indicated or reperfusion cannot be achieved by intravenous t-PA administration 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 Patients with an NIHSS score of 8 to 30 Patients with an mRS score of 0 to 2 before onset Patients aged between 20 and 85 years (at the time of informed consent) 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: 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 Patients who have two or more different major cerebrovascular occlusions requiring treatment Patients with an allergy to contrast agents or who cannot receive them or those who have a serious metal allergy Patients who received heparin within 48 hours and have Partial Thromboplastin Time (PTT)/Activated Partial Thromboplastin Time (APTT) > twice the upper limit of normal 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 Patients with platelet count <30,000 /mm3 Patients with blood glucose levels <50 mg/dL Patients with uncontrolled hypertension (systolic BP >185 mmHg and diastolic BP >110 mmHg) Patients with expected life expectancy <90 days Female patients who are pregnant or breast feeding Patients who are participating in clinical trials of drugs or medical devices Patients disqualified from participation in the study by the investigator (sub-investigator) due to reasons other than the above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sakai, M.D., D.M. Sc
Organizational Affiliation
Kobe City Medical Center General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Brain Attack Center Ota Memorial Hospital
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
Ise Red Cross Hospital
City
Ise
State/Province
Mie
Country
Japan
Facility Name
Kohnan Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daiichi Hospital
City
Kyoto
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
Country
Japan
Facility Name
Yamagata City Hospital SAISEIKAN
City
Yamagata
Country
Japan

12. IPD Sharing Statement

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

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