NCT01983644

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
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.
DEVICE	Solitaire FR flow restoration device	Solitaire FR flow restoration device has been approved by the FDA and CFDA.

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-11-14
• Last updated: 2018-07-26

Locations

10 sites across 1 country: China