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The study is a randomized, prospective, parallel-group, multicenter, open-label, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(Catfish) or Solitaire for endovascular therapy for acute ischemic stroke. The study aims to evaluate the benefit and safety of stent retriever(Catfish) for acute ischemic stroke therapy, as compared to Solitaire FR.
The main objective is to determine whether stent retriever(Catfish) will have non-inferior successful recanalization rate compared to Solitaire in patients with acute ischemic stroke caused by large vessel occlusion.
The secondary objectives is to verify whether there is significant differences in time from artery puncture to successful recanalization (mTICI 2b or greater), NIHSS score at 24 hours and at 7 days or discharge if earlier, good clinical outcomes at 90 days (defined as mRS score ≤2) between stent retriever(Catfish) and Solitaire in patients with acute ischemic stroke caused by large vessel occlusion.
The third objectives is to compare the rate of symptomatic intracranial hemorrhage, serious adverse event(SAE), all cause of mortality with 90 days after operation, between stent retriever (Catfish) and Solitaire in patients with acute ischemic stroke due to large vessel occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stent retriever(Catfish) | Experimental | Mechanical thrombectomy with Catfish flow restoration device |
|
| stent retriever(Solitaire FR) | Active Comparator | Mechanical thrombectomy with Solitaire FR flow restoration device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catfish | Device | Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure | Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA(digital subtraction angiography ) intraoperative immediately in both treatment groups | immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve recanalization | The period from femoral artery puncture to successful recanalization | intraprocedure immediate |
| NIHSS score at 24±2 hours | National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongrong Miao, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan hospital, Capital Medical University | Beijing | Beijing Municipality | 10000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37045544 | Derived | Luo G, Yan X, Xiao G, Wei L, Nai Bi Jiang YLK, Ma R, Chen W, Fang C, Zhou Z, Wan J, Peng Y, Zhang G, Zhao J, Li L, Yuan H, Wu J, Li B, Zhang F, Cheng Y, Gao F, Miao Z. Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent largevessel occlusion stroke: a prospective randomised controlled study. Stroke Vasc Neurol. 2023 Dec 29;8(6):435-443. doi: 10.1136/svn-2022-002036. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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prospective, randomized, open-label, parallel assignment
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| Solitaire FR | Device | Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management. |
|
| 24±2 hours |
| NIHSS score at 7±1 days or discharge | National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits | 7±1 days |
| proportion of patients who got a mRS 0-2 at 90±14 days | The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment.the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death) | 90±14 days |
| symptomatic intracranial hemorrhage after procedure | sICH was defined as any type of ICH on neuroimaging after the treatment within 24±2 hours after procedure with increasing of ≥4 points on NIHSS, National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits | 24±2 hours |
| serious adverse event(SAE) within 90±14 days after procedure | 90±14 days |
| all cause of mortality within 90±14 days after procedure | 90±14 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |