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

Ischemic Stroke Clinical Trial

— REDIRECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983644
• Other study ID #: REDIRECT
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

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.
• Solitaire FR flow restoration device
Solitaire FR flow restoration device has been approved by the FDA and CFDA.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	intracranial hemorrhages	Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure	24 hours
Secondary	all-cause mortality at 90 days		procedure through 90 days