A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Changhai Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reperfusion rate (mTICI≥2b)
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Jian-min Liu
Department of Neurosurgery, Changhai hospital
Changhai Hospital
Eligibility Criteria
Inclusion Criteria
- •age over 18 years;
- •clinical diagnosis should be acute ischaemic stroke;
- •no more than 6 hours after onset;
- •IV tPA thrombolysis, if needed, should start within 4.5 hours after onset；
- •Pre-stroke mRS ≤2;
- •ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;'
- •written informed consent form given
Exclusion Criteria
- •. history of intracranial hemorrhage.
- •. life expectancy \<90 days;
- •. history of major surgery or severe trauma in the past 10 days;
- •. Uncontrolled hypertension (defined as: SBP\>185mmHg or DBP ≥110 mm Hg at 3 continuous measurements with interval of at least 10 minutes confirm the SBP\>185mmHg or DBP ≥110 mm Hg)
- •. PLT\<40\*10\^9/L；
- •. blood glucose \<2.7mmol /L or \>
- •. concomitant use of oral anticoagulation drugs, and INR \>3.0；
- •. ASPECTS score ≤5；
- •. conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).
Outcomes
Primary Outcomes
Reperfusion rate (mTICI≥2b)
Time Frame: immediately after thrombectomy procedure
The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory
Functional outcome
Time Frame: 3 months after thrombectomy procedure
the percentage of functional independence as assessed by mRS (modified Rankin Scale) score\<3
Secondary Outcomes
- Number of passes of ReVive SE for each patient(within 3 hours after groin puncture)
- Procedure time(within 3 hours after groin puncture)
- Incidence of downstream embolization(within 3 hours after groin puncture)
- Incidence of embolization into new territories during intervention(within 3 hours after groin puncture)
- Incidence of symptomatic intracranial hemorrhage(within 24 hours after operation)
- Mortality(3 months)
- Device or intervention related adverse events(within 90 days after intervention)