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.
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.
- Revive SE intracranial thrombectomy device Device
Intervention Desc: Intra-arterial mechanical thrombectomy with Revive SE； According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion
Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device
|Type||Measure||Time Frame||Safety Issue|
|Primary||Reperfusion rate (mTICI≥2b)||immediately after thrombectomy procedure|
|Primary||Functional outcome||3 months after thrombectomy procedure|
|Secondary||Procedure time||within 3 hours after groin puncture|
|Secondary||Number of passes of ReVive SE for each patient||within 3 hours after groin puncture|
|Secondary||Incidence of downstream embolization||within 3 hours after groin puncture|
|Secondary||Incidence of embolization into new territories during intervention||within 3 hours after groin puncture|
|Secondary||Incidence of symptomatic intracranial hemorrhage||within 24 hours after operation|
|Secondary||Device or intervention related adverse events||within 90 days after intervention|
- Changhai Hospital Lead