Ischemic Stroke
Conditions
Keywords
acute ischemic stroke,endovascular recanalization, mechanical thrombectomy
Brief summary
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.
Detailed description
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.
Interventions
DEVICERECO flow restoration device
RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
DEVICESolitaire FR flow restoration device
Solitaire FR flow restoration device has been approved by the FDA and CFDA.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revascularization Status | Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment | Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (\<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower . Grade 3:Complete Perfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes at 90 Days | 90-day | Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms. |
| intracranial hemorrhages | 24 hours | Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure |
| all-cause mortality at 90 days | procedure through 90 days | — |
Countries
China
Outcome results
None listed