RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
REDIRECT
1 other identifier
interventional
130
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 26, 2018
December 1, 2016
4.3 years
November 4, 2013
July 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Clinical Outcomes at 90 Days
90-day
intracranial hemorrhages
24 hours
all-cause mortality at 90 days
procedure through 90 days
Study Arms (2)
RECO thrombectomy
EXPERIMENTALIA 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 COMPARATORIA thrombectomy is executed by Solitaire FR flow restoration device
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Daping Hospital
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital
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
Related Publications (2)
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.
PMID: 32502991DERIVEDJiang 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.
PMID: 26514251DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xinfeng Liu, MD
Department of Neurology, Jinling Hospital, Nanjing 210002, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 4, 2013
First Posted
November 14, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 26, 2018
Record last verified: 2016-12