RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT)

RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: RECO flow restoration device; Device: Solitaire FR flow restoration device

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Daping Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Fuzhou General Hospital
    • Xiamen, Fujian, China
      • Zhongshan Hospital of Xiamen University
  • Hubei
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China, 210002
      • Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
    • Suzhou, Jiangsu, China
      • Second Affiliated Hospital of Soochow University
    • Yangzhou, Jiangsu, China
      • Yangzhou First People's Hospital
  • Shandong
    • Qingdao, Shandong, China
      • Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age (18-80 years)
2. acute ischemic stroke
3. within 8 hours after symptom onset
4. a large-vessel confirmed by CTA/MRA (eg, internal carotid, middle cerebral M1 and/or M2 segments)
5. NIHSS(≥8 and ≤24)
6. patients or their legally authorised representatives provided signed, informed consent.

Exclusion Criteria:

1. CT or MRI evidence of intracranial haemorrhage/tumor
2. major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory)
3. NIHSS(≥25 and ≤7)
4. severe sustained hypertension (systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg)
5. baseline glucose concentrations of less than 2·7 mmol/L or higher than 21.6 mmol/L
6. known haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with an international normalised ratio of more than 1.7
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
8. history of severe allergy (worse than rash) to contrast medium or nitinol
9. pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: RECO flow restoration device; RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.; Other Names: RECO
Active Comparator: Solitaire FR thrombectomy; IA thrombectomy is executed by Solitaire FR flow restoration device	Device: Solitaire FR flow restoration device; Solitaire FR flow restoration device has been approved by the FDA and CFDA.; Other Names: Solitaire FR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure	24 hours
all-cause mortality at 90 days		procedure through 90 days

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Chair: Xinfeng Liu, MD, Department of Neurology, Jinling Hospital, Nanjing 210002, China

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: mechanical thrombectomy; acute ischemic stroke,endovascular recanalization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: REDIRECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED