Clinical trial NCT01983644: RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
Official title: RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke,endovascular recanalization
mechanical thrombectomy
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Revascularization Status
timeFrame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Secondary outcomes:
measure: Clinical Outcomes at 90 Days
timeFrame: 90-day
measure: intracranial hemorrhages
timeFrame: 24 hours
measure: all-cause mortality at 90 days
timeFrame: procedure through 90 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital of Xiamen University
state: Fujian
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changzhou
country: China
facility: First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
state: Jiangsu
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: Department of Neurology, Jinling Hospital, Nanjing 210002, China
name: Xinfeng Liu, MD
role: STUDY_CHAIR
References:
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. Print 2021 May 1.
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.