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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02964702
• Date of registration: 09/11/2016
• Prospective Registration: Yes
• Primary sponsor: JIMRO Co., Ltd.
• Public title: Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan) TRON1-Japan
• Scientific title: A Multicenter, Single-arm Study of the Efficacy and Safety of a Thrombectomy Device (T-01) for the Treatment of Acute Cerebral Infarction
• Date of first enrolment: November 9, 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02964702
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Nobuyuki Sakai, M.D., D.M. Sc
• Affiliation: Kobe City Medical Center General Hospital

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Ischemic Stroke

Intervention(s)

Device: Thrombectomy Device T-01

Primary Outcome(s)

The primary safety endpoint of the study is mortality within 90 days after the procedure [Time Frame: 90 days]

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]

Secondary Outcome(s)

Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy [Time Frame: immediate post-procedure]

Assessment of Barthel Index (BI) scores at 90 days post-procedure [Time Frame: 90 days]

Assessment of NIHSS scores at 90 days post-procedure [Time Frame: 90 days]

Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure [Time Frame: 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]

Incidence of device- or procedure-related serious adverse events within 90 days after the procedure [Time Frame: 90 days]

Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure [Time Frame: 24 hours]

Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure [Time Frame: 24 hours]

Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure [Time Frame: 24 hours]

Assessment of mRS scores at 90 days post-procedure [Time Frame: 90 days]

Number of any defect in the investigational device [Time Frame: at the time of inspection before procedure, intraoperative and immediate post-procedure]

Secondary ID(s)

BJSTO-16-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors