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

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: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Thrombectomy Device T-01

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Thrombectomy Device(T-01); Mechanical Thrombectomy with T-01	Device: Thrombectomy Device T-01

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JIMRO Co., Ltd.
• Investigators: Principal Investigator: Nobuyuki Sakai, M.D., D.M. Sc, Kobe City Medical Center General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2016
• Primary Completion (ACTUAL): July 25, 2017
• Study Completion (ACTUAL): October 23, 2017

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 11, 2016
• First Posted (ESTIMATE): November 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BJSTO-16-01