Revive AIS Patients ImmeDiately

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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

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Ischemic Stroke Occlusion, Cerebrovascular

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Revive SE intracranial thrombectomy device

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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No