Ischemic Stroke, Occlusion, Cerebrovascular
Conditions
Keywords
endovascular treatment, mechanical thrombectomy, stent retriever, human
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.
Interventions
DEVICERevive 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
Sponsors
Changhai Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of downstream embolization | within 3 hours after groin puncture | — |
| Incidence of embolization into new territories during intervention | within 3 hours after groin puncture | — |
| Procedure time | within 3 hours after groin puncture | the time take to achieve successful reperfusion (from groin puncture to reperfusion) |
| Mortality | 3 months | — |
| Device or intervention related adverse events | within 90 days after intervention | — |
| Incidence of symptomatic intracranial hemorrhage | within 24 hours after operation | — |
| Number of passes of ReVive SE for each patient | within 3 hours after groin puncture | — |
Countries
China
Contacts
Primary ContactPeng-fei Yang, MD
Backup ContactWan-ling Wen, MD
Outcome results
None listed