ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Suspended

Phase N/A Results N/A

Update History

7 Sep '12
A location was updated in Chicago.
New
The overall status was removed for Rush Medical Center.
A location was updated in Kansas City.
New
The overall status was removed for St Luke's Hospital of Kansas City.
A location was updated in Portland.
New
The overall status was removed for Oregon Health & Science University.
A location was updated in Chattanooga.
New
The overall status was removed for Tennessee Interventional Associates, Erlanger Medical Ctr.
28 Oct '11
A location was updated in Chattanooga.
New
The overall status was removed for Tennessee Interventional Associates, Erlanger Medical Ctr.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - 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 Criteria: - 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.
Old
Inclusion Criteria: - 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 Criteria: - 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.