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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
Solitaire FR flow restoration device has been approved by the FDA and CFDA.
Daping Hospital
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital
Fuzhou, Fujian, China
Zhongshan Hospital of Xiamen University
Xiamen, Fujian, China
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.
Time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
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.
Time frame: 90-day
intracranial hemorrhages
Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure
Time frame: 24 hours
all-cause mortality at 90 days
Time frame: procedure through 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China