RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 10
- Primary Endpoint
- Revascularization Status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RECO thrombectomy
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.
Intervention: RECO flow restoration device (Device)
Solitaire FR thrombectomy
IA thrombectomy is executed by Solitaire FR flow restoration device
Intervention: Solitaire FR flow restoration device (Device)
Outcomes
Primary Outcomes
Revascularization Status
Time Frame: 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 Outcomes
- Clinical Outcomes at 90 Days(90-day)
- all-cause mortality at 90 days(procedure through 90 days)
- intracranial hemorrhages(24 hours)
Investigators
Xinfeng Liu
Professor
Jinling Hospital, China