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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: RECO flow restoration device; Device: Solitaire FR flow restoration device

• Registration Number: NCT01983644
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Status Verified: 2016-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RECO thrombectomy	RECO flow restoration device	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	Solitaire FR flow restoration device	IA thrombectomy is executed by Solitaire FR flow restoration device

Primary Outcome Measures

Name	Time	Method
Revascularization Status	Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment	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

Name	Time	Method
Clinical Outcomes at 90 Days	90-day	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.
all-cause mortality at 90 days	procedure through 90 days
intracranial hemorrhages	24 hours	Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure

Trial Locations

Locations (10)

Daping Hospital; 🇨🇳 Chongqing, Chongqing, 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, China

Yangzhou First People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China