Ischemic Cerebrovascular AccidentPhase 2NCT02347358
Mechanical Opening Device Implantation Following Intravenous r-tPA for Recanalization in Acute Ischemic Stroke
A Phase 2 study testing JRecanTM blood FR device and IV r-tPA in people with Ischemic Cerebrovascular Accident, run by The Second Artillery General Hospital.
Trial summary
This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Cerebrovascular Accident
- What is being tested?
- JRecanTM blood FR device and IV r-tPA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2017
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75
- Clinical presentations consistent with acute ischemic stroke
- NIHSS ≥ 8 and < 30 at the time of randomization
- Initiation of the correct IV t-PA dose treatment within 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline)
- Complement of catheter angiography within 6.5 hours of onset of stroke symptoms
- Thrombolysis in myocardial Infarction (TIMI) 0-1 flow in the intracranial internal carotid artery, M1 segment of the MCA, basilar artery, or intracranial vertebral artery with contralaterally chronic intracranial vertebral artery occlusion confirmed by catheter angiography
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- The acute occlusion lesion is accessible to the JRecanTM blood flow recanalisation device
- Functional independence before this time stroke (Modified Rankin Score ≤ 1)
- Subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to country regulations, ethics committee requirements.
- Subject is willing to conduct protocol-required follow-up visits.
Who cannot join
- NIHSS <8 or ≥30
- Rapid neurological improvement prior to study randomization
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Taking part in another clinical study.
- History of stroke in the past 3 months.
- Current participation in another investigational drug or device treatment study.
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- Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication.
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (Patients without history or suspicion of coagulopathy do not require INR or prothrombin time lab results to be available prior to enrollment.)
- Warfarin therapy with INR greater than 1.7.
- Low molecular Weight Heparins (such as Dalteparin, Enoxaparin, Tinzaparin, Fondaparinux) as DVT prophylaxis or in full dose within the last 24 hours from screening.
- Subject who has received heparin or a direct thrombin inhibitor (e.g. rivaroxaban, Angiomax™, argatroban, Refludan™) within the last 48 hours must have a normal partial thromboplastin time (PTT) to be eligible.
- Subject who has received factor Xa inhibitor therapy (e.g. dabigatran) within the past 24 hours must have a normal ecarin clotting time to be eligible. Subject who has received factor Xa inhibitor therapy more than 24 hours ago but less than 48 hours ago must have a normal partial thromboplastin time (PTT) to be eligible.
- Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets < 100,000, or Hct < 25.
- Renal Failure as defined by a serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30.
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
- Life expectancy of less than 90 days.
- Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, cerebral aneurysm, or arteriovenous malformation.
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
- Presumed septic embolus, or suspicion of bacterial endocarditis.
- Presumed pericarditis including pericarditis after acute myocardial infarction.
- Suspicion of aortic dissection.
- Surgery or biopsy of parenchymal organ within 30 days.
- Trauma with internal injuries or ulcerative wounds within 30 days.
- Severe head trauma or head trauma with loss of consciousness within 90 days.
- Any active or recent hemorrhage within 30 days.
- Cerebral vasculitis.
- Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mechanical Opening Device Implantation Following Intravenous r-tPA and Recanalization Outcome Evaluation in Stroke Disease (MODIFIED) Trial
This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.
- Conditions
- Ischemic Cerebrovascular Accident
- Being tested
- JRecanTM blood FR device, IV r-tPA
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JRecanTM blood FR deviceDevice
JRecanTM blood flow recanalisation device
IV r-tPADrug
Also called intravenous recombinant human tissue plasminogen activator
intravenous recombinant human tissue plasminogen activator
| Study group | Role | What they receive |
|---|---|---|
| IV r-tPA with JRecanTM blood FR device | Experimental | Dual IV r-tPA therapy and adjunctive treatment with JRecanTM blood flow recanalisation device Receives: Device: JRecanTM blood FR device |
| IV r-tPA | Active comparator | IV infusion of r-tPA Receives: Drug: IV r-tPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early successful recanalisation (assessed by the imaging core laboratory)
TIMI（thrombolysis in myocardial infarction）2 or 3 recanalisation 1 hour after enrollment blindly assessed by the imaging core laboratory and without any presence of symptomatic intracranial hemorrhage within 24 hours blindly assessed by independent neurologists.
Measured: 24 hours
Secondary outcomes (3)
Good neurological outcome( modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale（NIHSS）score improvement of 10 points or more)
modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale（NIHSS）score improvement of 10 points or more.
Measured: 90 days
Incidence of device related and procedure-related serious adverse events(SAEs)
The incidence of device related and procedure-related serious adverse events(SAEs)
Measured: 30 days
Additional safety end-points (symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days)
symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cerebrovascular AccidentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Artillery General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Rui Kang Tong technology development co., LTD
- Responsible party
- Principal investigator, Weijian Jiang, The Second Artillery General Hospital
- Investigators
- Weijian Jiang, MD,PhD, Principal investigator, New Era Stroke Care and Research Institute, The Second Artillery General Hospital Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347358
- Sponsor's protocol ID
- 2013CB733805
- Status last verified
- Jan 2015
- First submitted
- 10 Jan 2015
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Opening Device Implantation Following Intravenous r-tPA and Recanalization Outcome Evaluation in Stroke Disease (MODIFIED) Trial
- ClinicalTrials.gov ID
- NCT02347358
- Acronym / sponsor ID
- 2013CB733805
- Conditions
- Ischemic Cerebrovascular Accident
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Artillery General HospitalUniversity, hospital or other
- Collaborators
- Hunan Rui Kang Tong technology development co., LTD
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 27 Jan 2015 (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.
This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV r-tPA with JRecanTM blood FR device | Experimental | Device: JRecanTM blood FR deviceDual IV r-tPA therapy and adjunctive treatment with JRecanTM blood flow recanalisation device |
| IV r-tPA | Active comparator | Drug: IV r-tPAIV infusion of r-tPA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 - 75
- Clinical presentations consistent with acute ischemic stroke
- NIHSS ≥ 8 and < 30 at the time of randomization
- Initiation of the correct IV t-PA dose treatment within 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline)
- Complement of catheter angiography within 6.5 hours of onset of stroke symptoms
Key exclusion criteria (27 listed)
- NIHSS <8 or ≥30
- Rapid neurological improvement prior to study randomization
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Taking part in another clinical study.
- History of stroke in the past 3 months.
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 |
|---|---|---|
| JRecanTM blood FR deviceJRecanTM blood flow recanalisation device | Device | IV r-tPA with JRecanTM blood FR device |
| IV r-tPAAlso: intravenous recombinant human tissue plasminogen activatorintravenous recombinant human tissue plasminogen activator | Drug | IV r-tPA |
Primary outcome
Early successful recanalisation (assessed by the imaging core laboratory)
Time frame: 24 hours
TIMI（thrombolysis in myocardial infarction）2 or 3 recanalisation 1 hour after enrollment blindly assessed by the imaging core laboratory and without any presence of symptomatic intracranial hemorrhage within 24 hours blindly assessed by independent neurologists.
3 secondary outcomes
Good neurological outcome( modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale（NIHSS）score improvement of 10 points or more)
Time frame: 90 days
Incidence of device related and procedure-related serious adverse events(SAEs)
Time frame: 30 days
Additional safety end-points (symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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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.
Weijian Jiang, MD,PhD principal investigator
New Era Stroke Care and Research Institute, The Second Artillery General Hospital Beijing
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JRecanTM blood FR device and IV r-tPA in people with Ischemic Cerebrovascular Accident, run by The Second Artillery General Hospital.
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 10 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weijian Jiang, MD,PhD (+8613901122837, cjr.jiangweijian@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early successful recanalisation (assessed by the imaging core laboratory) (time frame: 24 hours). 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 27 Jan 2015.