Clinical trial NCT03007082: Revive AIS Patients ImmeDiately
Official title: A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Occlusion, Cerebrovascular
Keywords: endovascular treatment
mechanical thrombectomy
stent retriever
human
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Reperfusion rate (mTICI≥2b)
timeFrame: immediately after thrombectomy procedure
measure: Functional outcome
timeFrame: 3 months after thrombectomy procedure
Secondary outcomes:
measure: Procedure time
timeFrame: within 3 hours after groin puncture
measure: Number of passes of ReVive SE for each patient
timeFrame: within 3 hours after groin puncture
measure: Incidence of downstream embolization
timeFrame: within 3 hours after groin puncture
measure: Incidence of embolization into new territories during intervention
timeFrame: within 3 hours after groin puncture
measure: Incidence of symptomatic intracranial hemorrhage
timeFrame: within 24 hours after operation
measure: Mortality
timeFrame: 3 months
measure: Device or intervention related adverse events
timeFrame: within 90 days after intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Changhai hospital, Shanghai
name: Jian-min Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Wen W, Chen C, Wu Z, Xiang X, Shi H, Guan S, Jiang G, Peng Y, Li Z, Li Z, Zhang L, Zhang Y, Hong B, Yang P, Liu J. Effectiveness of Revive SE in the RAPID registry : Revive Acute Ischemic Stroke Patients ImmeDiately (RAPID) Prospective Multicenter Trial. Clin Neuroradiol. 2020 Sep;30(3):495-502. doi: 10.1007/s00062-019-00798-w. Epub 2019 Jun 7.