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

Jinling Hospital, China

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: Solitaire FR flow restoration device; Device: RECO flow restoration device

Study type: Interventional

Funder types: Other

Identifiers

NCT01983644

REDIRECT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

RECO thrombectomy

Experimental group

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.

Treatment:

Device: RECO flow restoration device

Solitaire FR thrombectomy

Active Comparator group

Description:

IA thrombectomy is executed by Solitaire FR flow restoration device

Treatment:

Device: Solitaire FR flow restoration device