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This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Eligible patients with acute ischemic stroke due to internal carotid artery intracranial segment and/or middle cerebral artery M1 occlusion will be randomized 1:1 to receive either aspiration using a super large bore catheter (inner diameter ≥0.080 inch) or stent retriever thrombectomy (allowing balloon guiding catheters or intermediate catheters with inner diameter <0.080 inch). The primary outcome is the ordinal modified Rankin Scale score at 90 days post-procedure. Key secondary outcomes include the proportion of patients with mRS 0-2 at 90 days, change in NIHSS at 24 hours and 7 days, and various angiographic and safety endpoints. The trial plans to enroll 708 patients across approximately 30 centers in China. The total study duration is 24-36 months, with each patient participating for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super Large Bore Catheter Aspiration | Experimental | A super large bore aspiration catheter with an inner diameter (ID) ≥0.080 inch is preferred as the first-line device for simple aspiration thrombectomy. |
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| Stent Retriever Thrombectomy | Active Comparator | Stent retriever thrombectomy is preferred as the first-line technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super Large Bore Catheter | Procedure | The SLBC group may switch to different super large bore aspiration catheters. Once the aspiration catheter contacts the thrombus, continuous negative pressure aspiration is maintained for 1 minute. A total of at least three aspiration attempts should be performed using aspiration catheters of different inner diameters. If the catheter fails to contact the thrombus despite using different inner diameter catheters, or if complete recanalization is not achieved after three attempts, or if new embolization occurs in the M2 segment or other vascular territories, the investigator may decide, as deemed necessary, to continue attempting with the original device or to use other techniques and devices for recanalization. In cases where angiography shows that the thrombus has migrated forward and can no longer be aspirated using a super large bore catheter, and continued thrombectomy is judged necessary, other rescue techniques may be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal modified Rankin Scale score | The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.
| 90 days (±7 days) post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Scale score 0-2 | The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.
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| Measure | Description | Time Frame |
|---|---|---|
| Aspiration catheter delivery success rate | Defined as successful delivery of the aspiration catheter to the target occluded vessel, contacting the tail of the thrombus, or contacting the tail of the stent retriever before retrieval. | During the procedure |
| Final angiographic reperfusion status |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueqi Zhu, MD | Contact | 18930173115 | zhuyueqi@sjtu.edu.cn | |
| Jiangshan Deng, MD | Contact | 18817822181 | jiangshandeng@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yueqi Zhu, MD | Shanghai Sixth Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Principal Investigator |
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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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| Stent Retriever Thrombectomy | Procedure | Stent retriever thrombectomy is performed as the first line approach. Allowed to employ adjunctive technology during the stent retriever passes according to physician preference, which may be combined with an aspiration catheter (inner diameter < 0.080 inch). The use of a large-bore aspiration catheter (inner diameter > 0.080 inch) is prohibited in this arm. |
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| 90 days (±7 days) post-procedure |
| Other binary classifications of modified Rankin Scale score | Modified Rankin Scale score 0-1 vs. 2-6, 0-3 vs. 4-6, 0-4 vs. 5-6, 0-5 vs. 6. The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.
| 90 ± 7 days post-procedure |
| Change in stroke severity (National Institutes of Health Stroke Scale score) | Change of NIHSS score at 24h from baseline. The NIHSS is a standardized, validated tool used to quantify the severity of neurological deficits in patients with acute stroke. Score range: 0 to 42 (higher scores indicate more severe stroke). | 24 hours post-procedure |
| Change in stroke severity (National Institutes of Health Stroke Scale score) | Change of NIHSS score at 7 days post-procedure or at discharge from baseline. The NIHSS is a standardized, validated tool used to quantify the severity of neurological deficits in patients with acute stroke. Score range: 0 to 42 (higher scores indicate more severe stroke). | 7 days post-procedure or at discharge (whichever occurs first) |
eTICI 0 - No reperfusion. eTICI 1 - Minimal reperfusion (flow past the occlusion but no distal branch filling). eTICI 2a - Reperfusion <50% of the occluded target artery territory. eTICI 2b - Reperfusion ≥50% but <90%. eTICI 2c - Reperfusion ≥90% (near complete, only slow flow or small distal clot). eTICI 3 - Complete (100%) reperfusion. |
| Immediately after procedure |
| Reperfusion status after first-line technique thrombectomy | eTICI 0 - No reperfusion. eTICI 1 - Minimal reperfusion (flow past the occlusion but no distal branch filling). eTICI 2a - Reperfusion <50% of the occluded target artery territory. eTICI 2b - Reperfusion ≥50% but <90%. eTICI 2c - Reperfusion ≥90% (near complete, only slow flow or small distal clot). eTICI 3 - Complete (100%) reperfusion. | During the procedure after the first-line technique thrombectomy |
| First-pass successful reperfusion rate | First-pass successful reperfusion defined as reperfusion ≥90% (eTICI 2c) after first pass. | During the procedure after the first thrombectomy |
| Time from arterial puncture to successful reperfusion (≥ eTICI 2b) | Successful reperfusion defined as reperfusion status ≥ eTICI 2b | During the procedure, time from puncture to successful reperfusion (≥ eTICI 2b) achieved |
| Time from arterial puncture to successful reperfusion (≥ eTICI 2c) | Successful reperfusion defined as reperfusion status ≥ eTICI 2c | During the procedure, time from puncture to successful reperfusion (≥ eTICI 2c) achieved |
| Proportion of patients achieving reperfusion (≥ eTICI 2b) within 45 minutes of puncture | Achieving revascularization defined as reperfusion status ≥ eTICI 2b | During the procedure, 45 minutes after puncture. |
| Proportion of patients achieving reperfusion (≥ eTICI 2c) within 45 minutes of puncture | Achieving revascularization defined as reperfusion status ≥ eTICI 2c | During the procedure, 45 minutes after puncture. |
| Proportion of patients achieving revascularization (eTICI 3) within 45 minutes of puncture | Achieving revascularization defined as reperfusion status with eTICI 3 | During the procedure, 45 minutes after puncture. |
| Total number of final thrombectomy passes to achieve successful recanalization | Successful recanalization defined as reperfusion status≥ eTICI 2c) | During the procedure |
| Proportion of patients with embolization to a new territory (non-culprit vascular territory) | Embolization to a new territory not within the artery of thrombectomy | During the procedure |
| Proportion of patients with distal embolization of the culprit vessel territory | Embolization to the distal area of the culprit artery | During the procedure |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |