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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RECO thrombectomy | Experimental | 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. |
|
| Solitaire FR thrombectomy | Active Comparator | IA thrombectomy is executed by Solitaire FR flow restoration device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECO flow restoration device | Device | RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinfeng Liu, MD | Department of Neurology, Jinling Hospital, Nanjing 210002, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital | Chongqing | Chongqing Municipality | China | |||
| Fuzhou General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32502991 | Derived | Cao J, Lin H, Lin M, Ke K, Zhang Y, Zhang Y, Zheng W, Chen X, Wang W, Zhang M, Xuan J, Peng Y; REDIRECT Trial Investigators. RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial. J Neurosurg. 2020 Jun 5;134(5):1569-1577. doi: 10.3171/2020.3.JNS193356. Print 2021 May 1. | |
| 26514251 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Solitaire FR flow restoration device | Device | Solitaire FR flow restoration device has been approved by the FDA and CFDA. |
|
|
Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure
| 24 hours |
| all-cause mortality at 90 days | procedure through 90 days |
| Fuzhou |
| Fujian |
| China |
| Zhongshan Hospital of Xiamen University | Xiamen | Fujian | China |
| 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 | 210002 | 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 |
| Jiang Y, Li Y, Xu X, Yu Y, Liu W, Liu X. An in vitro porcine model evaluating a novel stent retriever for thrombectomy of the common carotid artery. Catheter Cardiovasc Interv. 2016 Feb 15;87(3):457-64. doi: 10.1002/ccd.26285. Epub 2015 Oct 30. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |