NCT03007082

Revive AIS Patients ImmeDiately

A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective registry clinical study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE device on the basis of standardised medical treatment.

Detailed description

This is a multi-center, prospective, single-arm observational study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients using Revive SE device on the basis of standardised medical treatment.The device selection before treatment is based upon doctors who are blinded to the protocol. The primary outcomes are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90 days after intervention.

Conditions

• Ischemic Stroke
• Occlusion, Cerebrovascular

Interventions

Type	Name	Description
DEVICE	Revive SE intracranial thrombectomy device	1. Intra-arterial mechanical thrombectomy with Revive SE； 2. According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-01-02
• Last updated: 2017-01-06

Locations

1 site across 1 country: China