Revive AIS Patients ImmeDiately "RAPID"

Recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • 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

Trial Population

Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device

Outcomes

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 Mortality 3 months
Secondary Device or intervention related adverse events within 90 days after intervention

Sponsors