Acute Ischemic StrokeTRON1-JapanNCT02964702
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)
A study testing Thrombectomy Device T-01 in people with Acute Ischemic Stroke, run by JIMRO Co., Ltd. at 13 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Thrombectomy Device T-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 13 sitesJapan
- Study dates
- 9 Nov 2016to 23 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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)
- Patients with expected life expectancy <90 days
- Female patients who are pregnant or breast feeding
- Patients who are participating in clinical trials of drugs or medical devices
- Patients disqualified from participation in the study by the investigator (sub-investigator) due to reasons other than the above
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Brain Attack Center Ota Memorial Hospital
Fukuyama, Hiroshima
Gifu University Hospital
Gifu
Ise Red Cross Hospital
Ise, Mie-ken
Kobe City Medical Center General Hospital
Kobe, Hyōgo
Kurume University Hospital
Kurume, Fukuoka
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto
Nagasaki University Hospital
Nagasaki
Hyogo College of Medicine
Nishinomiya, Hyōgo
Kohnan Hospital
Sendai, Miyagi
National Cerebral and Cardiovascular Center
Suita, Osaka
University of Tsukuba Hospital
Tsukuba, Ibaraki
Wakayama Medical University Hospital
Wakayama
Yamagata City Hospital SAISEIKAN
Yamagata
About this study
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
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
- Being tested
- Thrombectomy Device T-01
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombectomy Device T-01Device
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy Device(T-01) | Experimental | Mechanical Thrombectomy with T-01 Receives: Device: Thrombectomy Device T-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate post procedure
The primary safety endpoint of the study is mortality within 90 days after the procedure
Measured: 90 days
Secondary outcomes (11)
Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
Measured: immediate post-procedure
Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage within 24 hours after the procedure
Measured: 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
Measured: 90 days
Assessment of mRS scores at 90 days post-procedure
Measured: 90 days
Assessment of NIHSS scores at 90 days post-procedure
Measured: 90 days
Assessment of Barthel Index (BI) scores at 90 days post-procedure
Measured: 90 days
Incidence of intracranial hemorrhage including both symptomatic and asymptomatic within 24 hours after the procedure
Measured: 24 hours
Incidence of symptomatic intracranial hemorrhage within 24 hours after the procedure
Measured: 24 hours
Incidence of asymptomatic intracranial hemorrhage within 24 hours after the procedure
Measured: 24 hours
Incidence of device- or procedure-related serious adverse events within 90 days after the procedure
Measured: 90 days
Number of any defect in the investigational device
Measured: at the time of inspection before procedure, intraoperative and immediate post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start9 Nov 2016
- Primary completion25 Jul 2017
- Study completion23 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- JIMRO Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuyuki Sakai, M.D., D.M. Sc, Principal investigator, Kobe City Medical Center General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964702
- Sponsor's protocol ID
- BJSTO-16-01
- Acronym
- TRON1-Japan
- Status last verified
- Jul 2019
- First submitted
- 9 Nov 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02964702
- Acronym / sponsor ID
- TRON1-Japan / BJSTO-16-01
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- JIMRO Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy Device(T-01) | Experimental | Device: Thrombectomy Device T-01Mechanical Thrombectomy with T-01 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- Patients who manifest the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombectomy Device T-01 | Device | Thrombectomy Device(T-01) |
Primary outcome
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
The primary safety endpoint of the study is mortality within 90 days after the procedure
Time frame: 90 days
11 secondary outcomes
Proportion of subjects with newly diagnosed embolism accompanied by immediate post-procedure embolectomy
Time frame: immediate post-procedure
Rate of reperfusion not accompanied by symptomatic intracranial hemorrhage 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
Assessment of mRS scores at 90 days post-procedure
Time frame: 90 days
Assessment of NIHSS scores at 90 days post-procedure
Time frame: 90 days
Assessment of Barthel Index (BI) 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
Incidence of 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 device- or procedure-related serious adverse events within 90 days after the 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobuyuki Sakai, M.D., D.M. Sc principal investigator
Kobe City Medical Center General Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombectomy Device T-01 in people with Acute Ischemic Stroke, run by JIMRO Co., Ltd. at 13 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: immediate post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.