Status:
SUSPENDED
ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients
Lead Sponsor:
Reverse Medical Corporation
Conditions:
Ischemic Stroke
Eligibility:
All Genders
22-85 years
Phase:
NA
Brief Summary
The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial will be randomized to tr...
Detailed Description
The objective of this study is to demonstrate substantial equivalence of the ReStore™ Thrombectomy Device with the legally marketed MERCI Retrieval System. The study will evaluate safety and efficacy ...
Eligibility Criteria
Inclusion
- Age ≥ 22 and ≤ 85 years
- Clinical signs consistent with the diagnosis of acute ischemic stroke
- Pre-stroke Modified Rankin Score ≤2
- National Institute of Health Stroke Scale (NIHSS) assessment score ≥8 and \<30
- Patient presents between 0 and 8 hours of onset of stroke symptoms
- Contraindicated for IV t-PA treatment (as specified by drug manufacturer's IFU) OR Acute ischemic stroke treated with intravenous thrombolytic therapy where vascular imaging (TCD, CTA, MRA, or angiography) shows a persistent occlusion after the end of the infusion treatment. NOTE:
- Treatment initiated within 8 hours after symptom onset (first retrieval pass made within 8 hours)
- Neurologic signs that are NOT rapidly improving (NIHSS score has NOT decreased by 4 or more points as determined prior to or at the time of treatment as compared to the initial screen;
- TIMI 0 or 1 flow in internal carotid, middle cerebral M1/M2 segments, basilar, or vertebral arteries confirmed by angiography which are accessible to the retrieval devices.
- Patient/patient legal authorized representative willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations
- Patient or legally authorized representative has given informed consent, and consent is documented.
Exclusion
- NIHSS ≥30 or comatose
- Known to be pregnant
- Serum glucose level \<50 mg/dL
- Excessive cervical arterial tortuousity that prevents placement of the retrieval devices
- Known hemorrhagic diathesis
- Patients exhibiting signs suggestive of or angiographic evidence of bilateral stroke
- Coagulation factor deficiency (or oral anticoagulation therapy with INR\>3.0)
- In receipt of heparin within 48 hours with a PTT \> 2x the lab normal
- Baseline platelets \<30,000 mm3
- Known serious sensitivity to intra-arterial radiographic contrast agents
- Severe sustained hypertension (systolic blood pressure \> 185 mmHg or diastolic \>110 mmHg)
- Baseline CT or MRI revealed significant mass effect with midline shift or greater than 1/3 of the MCA region with hypodensity (sulcal effacement and/or loss of gray-white differentiation is allowed)
- Neurologic signs that are rapidly improving at the time of treatment as measured by a decrease in NIHSS score of 4 or more points as determined prior to or at the time of treatment as compared to the initial screen
- CT or MRI evidence of hemorrhage on presentation
- CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
- Life expectancy \< 3 months
- Angiographic evidence of carotid dissection, or high grade stenosis (\> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or vasculitis
- At the discretion of the investigator, patients with co-morbidities associated with a life expectancy of less than 3 months or co-morbidities that could influence the study results or make clinical follow-up difficult will be excluded.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01437774
Start Date
October 1 2011
End Date
October 1 2013
Last Update
September 6 2012
Active Locations (4)
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1
Rush Medical Center
Chicago, Illinois, United States, 60612
2
St Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
3
Oregon Health & Science University
Portland, Oregon, United States, 97239
4
Tennessee Interventional Associates, Erlanger Medical Ctr
Chattanooga, Tennessee, United States, 37403