Revive AIS Patients ImmeDiately

Changhai Hospital100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Ischemic Stroke Occlusion, Cerebrovascular

Interventions

Revive SE intracranial thrombectomy deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age over 18 years; 2. clinical diagnosis should be acute ischaemic stroke; 3. no more than 6 hours after onset; 4. IV tPA thrombolysis, if needed, should start within 4.5 hours after onset； 5. Pre-stroke mRS ≤2; 6. ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;' 7. written informed consent form given Exclusion Criteria: 1. . history of intracranial hemorrhage. 2. . life expectancy \<90 days; 3. . history of major surgery or severe trauma in the past 10 days; 4. . 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) 5. . PLT\<40\*10\^9/L； 6. . blood glucose \<2.7mmol /L or \>22. 2 mmol /L； 7. . concomitant use of oral anticoagulation drugs, and INR \>3.0； 8. . ASPECTS score ≤5； 9. . conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).

Locations (1)

Changhai hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Reperfusion rate (mTICI≥2b)

The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory

Time frame: immediately after thrombectomy procedure

Functional outcome

the percentage of functional independence as assessed by mRS (modified Rankin Scale) score\<3

Time frame: 3 months after thrombectomy procedure

Secondary Outcomes

Procedure time

the time take to achieve successful reperfusion (from groin puncture to reperfusion)

Time frame: within 3 hours after groin puncture

Number of passes of ReVive SE for each patient

Time frame: within 3 hours after groin puncture

Incidence of downstream embolization

Time frame: within 3 hours after groin puncture

Incidence of embolization into new territories during intervention

Time frame: within 3 hours after groin puncture

Incidence of symptomatic intracranial hemorrhage

Time frame: within 24 hours after operation

Mortality

Time frame: 3 months

Device or intervention related adverse events

Time frame: within 90 days after intervention

Central Contacts

Peng-fei Yang, MD

CONTACT

15921196312 15921196312@163.com

Wan-ling Wen, MD

CONTACT

15721571004 wwljoy00@hotmail.com

Data from ClinicalTrials.gov

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