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

NCT02964702 | Completed

• 1 other identifier: BJSTO-16-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (1)

Thrombectomy Device(T-01)

EXPERIMENTAL

Mechanical Thrombectomy with T-01

Device: Thrombectomy Device T-01

Interventions

Thrombectomy Device T-01 DEVICE

Thrombectomy Device(T-01)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• JIMRO Co., Ltd.: lead

Study Sites (13)

Kurume University Hospital

Kurume, Fukuoka, Japan

Location

Brain Attack Center Ota Memorial Hospital

Fukuyama, Hiroshima, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Location

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Location

Ise Red Cross Hospital

Ise, Mie-ken, Japan

Location

Kohnan Hospital

Sendai, Miyagi, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Location

Gifu University Hospital

Gifu, Japan

Location

Japanese Red Cross Kyoto Daiichi Hospital

Kyoto, Japan

Location

Nagasaki University Hospital

Nagasaki, Japan

Location

Wakayama Medical University Hospital

Wakayama, Japan

Location

Yamagata City Hospital SAISEIKAN

Yamagata, Japan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nobuyuki Sakai, M.D., D.M. Sc

  Kobe City Medical Center General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 16, 2016
• Study Start: November 9, 2016
• Primary Completion: July 25, 2017
• Study Completion: October 23, 2017
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

JP (13)