RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study "REDIRECT"

Recruiting

Phase N/A Results N/A

Update History

30 Dec '15
Trial acronym was updated.
New
REDIRECT
Trial name was updated.
New
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
The Summary of Purpose was updated.
New
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel occlusion.
Old
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with the using of intravenous t-PA within 4.5 hours of stroke onset.
The description was updated.
New
RECO is a novel, self-expanding stent retriever, designed to yield rapid flow restoration in acute cerebral ischaemia. The proposed study is a multicenter, randomized, prospective, parallel-group, open-label clinical trial with a blinded outcome, to test the RECO(a novel, self-expanding stent retriever), as compared with Solitaire FR stent retriever.
Old
Currently, intravenous tissue plasminogen activator within 4.5 hours of stroke onset is the only proven treatment for acute ischemic stroke. However, recanalization rate within 24 hours after the administration of intravenous tissue plasminogen activator is low, especially when the occlusion site involves a large intracranial artery. The low recanalization rate has prompted the development of endovascular therapy. RECO is a novel, self-expanding stent retriever, designed to yield rapid flow restoration in acute cerebral ischaemia. The proposed study is a multicenter, randomized, prospective, parallel-group, open-label clinical trial with a blinded outcome, to test the new approach of endovascular thrombectomy, as compared with standard intravenous t-PA.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. age (18-80 years) 2. acute ischemic stroke 3. within 8 hours after symptom onset 4. a large-vessel confirmed by CTA/MRA (eg, internal carotid, middle cerebral M1 and/or M2 segments) 5. NIHSS(≥8 and ≤24) 6. patients or their legally authorised representatives provided signed, informed consent. Exclusion Criteria: 1. CT or MRI evidence of intracranial haemorrhage/tumor 2. major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory) 3. NIHSS(≥25 and ≤7) 4. severe sustained hypertension (systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg) 5. baseline glucose concentrations of less than 2·7 mmol/L or higher than 21.6 mmol/L 6. known haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with an international normalised ratio of more than 1.7 7. treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal, baseline platelet count of less than 100×10^9/L 8. history of severe allergy (worse than rash) to contrast medium or nitinol 9. pregnancy
Old
Inclusion Criteria: 1. age (18-80 years) 2. acute anterior-circulation ischemic stroke 3. within 4.5 hours after symptom onset 4. a large-vessel confirmed by CTA/MRA (eg, internal carotid, middle cerebral M1 and/or M2 segments) 5. NIHSS(≥8 and ≤24) 6. patients or their legally authorised representatives provided signed, informed consent. Exclusion Criteria: 1. CT or MRI evidence of intracranial haemorrhage/tumor 2. major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory) 3. NIHSS(≥25 and ≤7) 4. severe sustained hypertension (systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg) 5. baseline glucose concentrations of less than 2·7 mmol/L or higher than 21.6 mmol/L 6. known haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with an international normalised ratio of more than 1.7 7. treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal, baseline platelet count of less than 100×10^9/L 8. history of severe allergy (worse than rash) to contrast medium or nitinol 9. pregnancy
A location was updated in Nanjing.
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The overall status was updated to "Recruiting" at Department of Neurology, Jinling Hospital, Nanjing University School of Medicine.
24 Oct '15
The Summary of Purpose was updated.
New
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with the using of intravenous t-PA within 4.5 hours of stroke onset.
Old
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with the using of intravenous t-PA within 4.5 hours of stroke onset.
A location was updated in Nanjing.
New
The overall status was updated to "Recruiting" at Department of Neurology, Jinling Hospital, Nanjing University School of Medicine.