Acute Ischemic Stroke
Conditions
Keywords
Endovascular thrombectomy, Super Large Bore Catheter, Acute Ischemic Stroke
Brief summary
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.
Interventions
PROCEDURESuper Large Bore Catheter
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.
PROCEDUREStent Retriever Thrombectomy
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.
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. Clinically diagnosed with acute ischemic stroke, and pre-procedure imaging confirms that the culprit vessel is occlusion of the intracranial segment of the internal carotid artery and/or the middle cerebral artery M1 segment; 3. Pre-stroke modified Rankin Scale (mRS) score of 0-1; 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6; 5. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3; 6. Time from symptom onset to initiation of endovascular treatment (arterial puncture) \< 24 hours; symptom onset time is defined as the "last known well" time; 7. Intravenous thrombolysis and/or mechanical thrombectomy are performed according to local guidelines, and intravenous thrombolysis does not delay mechanical thrombectomy; 8. Written informed consent is obtained from the patient or a family member.
Exclusion criteria
1. Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds); 2. Imaging indicates an intracranial tumor (excluding meningiomas \<2 cm in diameter) or mass effect caused by a tumor, such as midline shift; 3. Cerebral embolism caused by infection or bacterial endocarditis; 4. The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion; 5. Pre-procedure imaging suggests that the lesion is due to dissection; 6. Previous intracranial aneurysm or vascular malformation in the culprit vessel; 7. Presence of a life-threatening illness within 6 months that would prevent 3-month follow-up; 8. Pregnancy, psychiatric illness, severe hepatic or renal insufficiency, severe heart failure; 9. Concurrent participation in another clinical drug or device study; 10. Metastatic tumor; 11. Systemic infection; 12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal modified Rankin Scale score | 90 days (±7 days) post-procedure | 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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. The higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with modified Rankin Scale score 0-2 | 90 days (±7 days) post-procedure | 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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. The higher scores mean a worse outcome. A modified Rankin Scale score 0-2 indicates independence. |
| Other binary classifications of modified Rankin Scale score | 90 ± 7 days post-procedure | 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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. The higher scores mean a worse outcome. |
| Change in stroke severity (National Institutes of Health Stroke Scale score) | 24 hours post-procedure | 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). |
Contacts
CONTACTYueqi Zhu, MD
CONTACTJiangshan Deng, MD
PRINCIPAL_INVESTIGATORYueqi Zhu, MD
Shanghai Sixth Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed