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

Study Overview
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Brief Summary
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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
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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.

Official Title
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RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: RECO flow restoration device
* Device: Solitaire FR flow restoration device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age (18-80 years) acute ischemic stroke within 8 hours after symptom onset a large-vessel confirmed by CTA/MRA (eg, internal carotid, middle cerebral M1 and/or M2 segments) NIHSS(≥8 and ≤24) patients or their legally authorised representatives provided signed, informed consent. Exclusion Criteria: CT or MRI evidence of intracranial haemorrhage/tumor major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory) NIHSS(≥25 and ≤7) severe sustained hypertension (systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg) baseline glucose concentrations of less than 2·7 mmol/L or higher than 21.6 mmol/L known haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with an international normalised ratio of more than 1.7 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 history of severe allergy (worse than rash) to contrast medium or nitinol pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECO thrombectomy<br>IA thrombectomy is executed by RECO flow restoration device which is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. | Device: RECO flow restoration device<br>* RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.<br>* Other names: RECO;|
| Active Comparator: Solitaire FR thrombectomy<br>IA thrombectomy is executed by Solitaire FR flow restoration device | Device: Solitaire FR flow restoration device<br>* Solitaire FR flow restoration device has been approved by the FDA and CFDA.<br>* Other names: Solitaire FR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revascularization Status | 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. | Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes at 90 Days | 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. | 90-day | 
| intracranial hemorrhages | Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure | 24 hours | 
| all-cause mortality at 90 days |  | procedure through 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke,endovascular recanalization, mechanical thrombectomy