Clinical trial NCT02964702: Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: JIMRO Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: immediate post procedure
measure: The primary safety endpoint of the study is mortality within 90 days after the procedure
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
timeFrame: immediate post-procedure
measure: Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure
timeFrame: 24 hours
measure: 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
timeFrame: 90 days
measure: Assessment of mRS scores at 90 days post-procedure
timeFrame: 90 days
measure: Assessment of NIHSS scores at 90 days post-procedure
timeFrame: 90 days
measure: Assessment of Barthel Index (BI) scores at 90 days post-procedure
timeFrame: 90 days
measure: Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure
timeFrame: 24 hours
measure: Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure
timeFrame: 24 hours
measure: Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure
timeFrame: 24 hours
measure: Incidence of device- or procedure-related serious adverse events within 90 days after the procedure
timeFrame: 90 days
measure: Number of any defect in the investigational device
timeFrame: at the time of inspection before procedure, intraoperative and immediate post-procedure
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Fukuyama
country: Japan
facility: Brain Attack Center Ota Memorial Hospital
state: Hiroshima
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Ise
country: Japan
facility: Ise Red Cross Hospital
state: Mie
city: Sendai
country: Japan
facility: Kohnan Hospital
state: Miyagi
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata City Hospital SAISEIKAN
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Nobuyuki Sakai, M.D., D.M. Sc
role: PRINCIPAL_INVESTIGATOR
References: