Back to resultsRECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT)
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RECO flow restoration device
Solitaire FR flow restoration device
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke,endovascular recanalization, mechanical thrombectomy
Eligibility Criteria
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
Sites / Locations
- Daping Hospital
- Fuzhou General Hospital
- Zhongshan Hospital of Xiamen University
- Zhongnan Hospital of Wuhan University
- First People's Hospital of Changzhou
- Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
- Affiliated Hospital of Nantong University
- Second Affiliated Hospital of Soochow University
- Yangzhou First People's Hospital
- Affiliated Hospital of Qingdao University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RECO thrombectomy
Solitaire FR thrombectomy
Arm Description
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.
IA thrombectomy is executed by Solitaire FR flow restoration device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
intracranial hemorrhages
Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure
all-cause mortality at 90 days
Full Information
NCT ID
NCT01983644
First Posted
November 4, 2013
Last Updated
July 23, 2018
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT01983644
Brief Title
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
Acronym
REDIRECT
Official Title
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute ischemic stroke,endovascular recanalization, mechanical thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RECO thrombectomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Solitaire FR thrombectomy
Arm Type
Active Comparator
Arm Description
IA thrombectomy is executed by Solitaire FR flow restoration device
Intervention Type
Device
Intervention Name(s)
RECO flow restoration device
Other Intervention Name(s)
RECO
Intervention Description
RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
Intervention Type
Device
Intervention Name(s)
Solitaire FR flow restoration device
Other Intervention Name(s)
Solitaire FR
Intervention Description
Solitaire FR flow restoration device has been approved by the FDA and CFDA.
Primary Outcome Measure Information:
Title
Revascularization Status
Description
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
Secondary Outcome Measure Information:
Title
Clinical Outcomes at 90 Days
Description
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
Title
intracranial hemorrhages
Description
Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure
Time Frame
24 hours
Title
all-cause mortality at 90 days
Time Frame
procedure through 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinfeng Liu, MD
Organizational Affiliation
Department of Neurology, Jinling Hospital, Nanjing 210002, China
Official's Role
Study Chair
Facility Information:
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Zhongshan Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Facility Name
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32502991
Citation
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.
Results Reference
derived
PubMed Identifier
26514251
Citation
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.
Results Reference
derived
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RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
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