ACTRN12611000969965
Terminated
Phase 2
A randomized controlled trial of intra-arterial reperfusion therapy after standard dose intravenous t-PA within 4.5 hours of ischemic stroke onset utilizing dual target vessel occlusion and penumbral mismatch imaging selection
Florey Institute of Neuroscience and Mental Health0 sites100 target enrollmentSeptember 9, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ischemic stroke
- Sponsor
- Florey Institute of Neuroscience and Mental Health
- Enrollment
- 100
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients presenting with anterior circulation acute ischaemic stroke eligible using standard criteria to receive IV tPA within 4\.5 hours of stroke onset
- •2\. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
- •3\. Patient's age is \>/\=18 years
- •4\. Intra\-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.
- •Imaging inclusion criteria
- •Dual target:
- •5\. Arterial occlusion on CTA or MRA of the ICA, M1 or M2
- •6\. Mismatch \- Using CT or MRI with a Tmax \>6 second delay perfusion volume and either CT\-rCBF or DWI infarct core volume.
- •a) Mismatch ratio of greater than 1\.2, and
- •b) Absolute mismatch volume of greater than 10 ml, and
Exclusion Criteria
- •1\. Intracranial haemorrhage (ICH) identified by CT or MRI
- •2\. Rapidly improving symptoms at the discretion of the investigator
- •3\. Pre\-stroke mRS score of \>/\= 2 (indicating previous disability)
- •4\. Inability to access the cerebral vasculature in the opinion of the neurointerventional team
- •5\. Contra indication to imaging with MR with contrast agents
- •6\. Participation in any investigational study in the previous 30 days
- •7\. Any terminal illness such that patient would not be expected to survive more than 1 year
- •8\. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
- •9\. Pregnant women (clinically evident)
- •10\. Previous stroke within last three months
Outcomes
Primary Outcomes
Not specified
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