Revive AIS Patients ImmeDiately

• Conditions: Ischemic Stroke; Occlusion, Cerebrovascular

• Registration Number: NCT03007082
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-28
• Status Verified: 2017-01
• Study First Posted: 2017-01-02
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reperfusion rate (mTICI≥2b)	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	3 months after thrombectomy procedure	the percentage of functional independence as assessed by mRS (modified Rankin Scale) score\<3

Secondary Outcome Measures

Name	Time	Method
Procedure time	within 3 hours after groin puncture	the time take to achieve successful reperfusion (from groin puncture to reperfusion)
Number of passes of ReVive SE for each patient	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

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, Shanghai, China