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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revive SE intracranial thrombectomy device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reperfusion rate (mTICI≥2b) | The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory | immediately after thrombectomy procedure |
| Functional outcome | the percentage of functional independence as assessed by mRS (modified Rankin Scale) score<3 | 3 months after thrombectomy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | the time take to achieve successful reperfusion (from groin puncture to reperfusion) | within 3 hours after groin puncture |
| Number of passes of ReVive SE for each patient | within 3 hours after groin puncture |
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Inclusion Criteria:
Exclusion Criteria:
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Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng-fei Yang, MD | Contact | 15921196312 | +86 | 15921196312@163.com |
| Wan-ling Wen, MD | Contact | 15721571004 | +86 | wwljoy00@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian-min Liu, MD | Department of Neurosurgery, Changhai hospital, Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31175375 | Derived | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |