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

Acute Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964702
• Other study ID #: BJSTO-16-01
• Status: Completed
• Phase: N/A
• Start date: November 9, 2016
• Est. completion date: October 23, 2017

Study information

• Verified date: July 2019
• Source: JIMRO Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 23, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke

Intervention

Device:
• Thrombectomy Device T-01

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
JIMRO Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The primary safety endpoint of the study is mortality within 90 days after the procedure		90 days
Secondary	Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy		immediate post-procedure
Secondary	Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure		24 hours
Secondary	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
Secondary	Assessment of mRS scores at 90 days post-procedure		90 days
Secondary	Assessment of NIHSS scores at 90 days post-procedure		90 days
Secondary	Assessment of Barthel Index (BI) scores at 90 days post-procedure		90 days
Secondary	Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure		24 hours
Secondary	Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure		24 hours
Secondary	Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure		24 hours
Secondary	Incidence of device- or procedure-related serious adverse events within 90 days after the procedure		90 days
Secondary	Number of any defect in the investigational device		at the time of inspection before procedure, intraoperative and immediate post-procedure