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To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super-Bore Thrombosis Aspiration Catheter treatment group | Experimental | For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter. |
|
| Conventional thrombectomy device treatment group | Active Comparator | For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super-Bore Thrombosis Aspiration Catheter treatment group | Procedure | For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, Mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| The Rates of First Pass Effect (eTICI2c-3) | Evaluate effect of thrombectomy on reperfusion | Within 5 minutes at final angiography of thrombectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of mRS 0-2 at 90 days | Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (± 14 days) after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracerebral hemorrhage (sICH) | sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death. | 24-48 hours after procedure |
| mortality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Hu, MD, PhD | Contact | +86 055162284313 | andinghu@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, MD, PhD | The First Affiliated Hospital of University of Science and Technology of China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | Anhui | China |
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| Conventional thrombectomy device treatment group | Procedure | For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter. |
|
| 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis); |
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
| 90 (± 14 days) after procedure |
Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100% |
| 90 (± 14 days) after 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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