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This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tianyi Revascularization Device | Experimental |
| |
| Solitaire FR Revascularization Device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tianyi Revascularization Device | Device | Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure | At immediate post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Times to revascularization(From groin puncture to final revascularization result) | At immediate post-procedure | |
| NIHSS score at 24h, 7-day or discharge | Within 24 hours,7-day or discharge post-procedure, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours | Within 24 hours post-procedure | |
| All causes of mortality at 90 days | at 90 days post-procedure | |
Inclusion Criteria:
Exclusion Criteria:
Clinical exclusion criteria:
Imaging exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Shanghai | China |
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| Solitaire FR Revascularization Device | Device | Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain |
|
| Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2 | at 90 days post-procedure |
| Device Technical Success | At immediate post-procedure |
| Occurrence of serious adverse events or adverse events related to device or procedure |
| at 90 days post-procedure |
| Occurrence of device defect | at 90 days post-procedure |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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