Mechanical Opening Device Implantation Following Intravenous r-tPA for Recanalization in Acute Ischemic Stroke
NCT ID: NCT02347358
Last Updated: 2015-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2015-02-28
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IV r-tPA with JRecanTM blood FR device
Dual IV r-tPA therapy and adjunctive treatment with JRecanTM blood flow recanalisation device
JRecanTM blood FR device
JRecanTM blood flow recanalisation device
IV r-tPA
IV infusion of r-tPA
IV r-tPA
intravenous recombinant human tissue plasminogen activator
Interventions
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JRecanTM blood FR device
JRecanTM blood flow recanalisation device
IV r-tPA
intravenous recombinant human tissue plasminogen activator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical presentations consistent with acute ischemic stroke
3. NIHSS ≥ 8 and \< 30 at the time of randomization
4. 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)
5. Complement of catheter angiography within 6.5 hours of onset of stroke symptoms
6. 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
7. The acute occlusion lesion is accessible to the JRecanTM blood flow recanalisation device
8. Functional independence before this time stroke (Modified Rankin Score ≤ 1)
9. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form according to country regulations, ethics committee requirements.
10. Subject is willing to conduct protocol-required follow-up visits.
Exclusion Criteria
2. Rapid neurological improvement prior to study randomization
3. Female who is pregnant or lactating or has a positive pregnancy test at time of admission
4. Taking part in another clinical study.
5. History of stroke in the past 3 months.
6. Current participation in another investigational drug or device treatment study.
7. Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication.
8. 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.)
9. Warfarin therapy with INR greater than 1.7.
10. Low molecular Weight Heparins (such as Dalteparin, Enoxaparin, Tinzaparin, Fondaparinux) as DVT prophylaxis or in full dose within the last 24 hours from screening.
11. 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.
12. 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.
13. Baseline lab values: glucose \< 50 mg/dl or \> 400 mg/dl, platelets \< 100,000, or Hct \< 25.
14. Renal Failure as defined by a serum creatinine \> 2.0 or Glomerular Filtration Rate \[GFR\] \< 30.
15. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
16. Life expectancy of less than 90 days.
17. Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, cerebral aneurysm, or arteriovenous malformation.
18. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
19. Presumed septic embolus, or suspicion of bacterial endocarditis.
20. Presumed pericarditis including pericarditis after acute myocardial infarction.
21. Suspicion of aortic dissection.
22. Surgery or biopsy of parenchymal organ within 30 days.
23. Trauma with internal injuries or ulcerative wounds within 30 days.
24. Severe head trauma or head trauma with loss of consciousness within 90 days.
25. Any active or recent hemorrhage within 30 days.
26. Cerebral vasculitis.
27. Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations.
18 Years
75 Years
ALL
No
Sponsors
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Hunan Rui Kang Tong technology development co., LTD
UNKNOWN
The Second Artillery General Hospital
OTHER
Responsible Party
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Weijian Jiang
Principal Investigator
Principal Investigators
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Weijian Jiang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
New Era Stroke Care and Research Institute, The Second Artillery General Hospital Beijing
Central Contacts
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Other Identifiers
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2013CB733805
Identifier Type: -
Identifier Source: org_study_id
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