Revive AIS Patients ImmeDiately (RAPID)

Naval Military Medical University

Status: Unknown

Conditions: Ischemic Stroke; Occlusion, Cerebrovascular

Treatments: Device: Revive SE intracranial thrombectomy device

Study type: Observational

Funder types: Other

Identifiers

NCT03007082

CHEC2016-119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).