Status:
COMPLETED
Concentric Retriever Device (CRD) in Acute Ischemic Stroke
Lead Sponsor:
Sidney Starkman
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary purpose is to study the safety and effectiveness of the Concentric Retriever Device(CRD)in ischemic stroke patients who undergo clot retrieval with the CRD within 8 hours of stroke symptom...
Detailed Description
The primary objective is to assess the safety and efficacy of the Concentric Retriever in the treatment of thrombotic occlusions originating in the internal carotid, middle cerebral (M1 and M2 segment...
Eligibility Criteria
Inclusion
- 1(a) -Patients who present within 8 hours of stroke onset and are not candidates for treatment with t-PA who have clinical signs consistent with the diagnosis of ischemic stroke such as impairment of language, motor function, sensation, cognition, and/or gaze, or vision.
- 1(b). Patients who have had an acute ischemic stroke treated with intravenous thrombolytic therapy where vascular imaging (TCD, CTA, MRA, angiography) shows a persistent occlusion after the end of the infusion treatment.
- 2\. Patients \> 18 years of age. 3. NIHSSS \> 7 4. Angiogram shows a thrombotic occlusion originating in the internal carotid, middle cerebral (M1 or M2 segment), basilar, posterior cerebral, or vertebral arteries.
- 5\. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Exclusion
- Patient is pregnant (if within child bearing age).
- Patient has baseline glucose of \< 50mg/dL (\<50 mg/mM).
- Patient has excessive arterial tortuosity that precludes the device from reaching the target area.
- Patient has known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 2.0.
- Patient received Heparin within 48 hours with a PTT greater than 2 times the lab normal.
- Patient has baseline platelets \< 30,000.
- Patient has history of severe allergy to intra-arterial contrast medium.
- Patient has severe, sustained hypertension (systolic blood pressure \> 185 mm Hg or diastolic blood pressure \> 110 mm Hg).
- NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled.
- CT Scan or MRI reveals significant mass effect with midline shift.
- Patient's angiogram shows an arterial stenosis (\>50%) proximal to the embolus.
- Patient's anticipated life expectancy is less than 3 months.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00203710
Start Date
October 1 2003
End Date
September 1 2004
Last Update
December 14 2015
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90024