A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion

Study Overview
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Brief Summary
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Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion.

Official Title
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A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion: A Multicentre, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial

Conditions
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Basilar Artery Occlusion, Endovascular Treatment

Intervention / Treatment
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* Procedure: Contact aspiration Thrombectomy
* Procedure: Stent retriever thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years; Acute basilar artery occlusion confirmed by CTA/MRA/DSA; Last known well to puncture time≤24 hours; pc-ASPECTS score≥6 points; Baseline NIHSS score≥10 points; Consent to endovascular treatment; Informed consent signed. Clinical Exclusion Criteria: Baseline mRS≥3 points; Known or suspected severe basilar artery stenosis (>70%) or chronic occlusion based on history, imaging, or clinical manifestations; Refractory hypertension that is difficult to be controlled by drugs (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) Genetic or acquired hemorrhagic tendency, coagulation factor deficiency or on anticoagulant therapy and International Normalized Ratio (INR) > 3.0; Laboratory tests: baseline blood glucose <50mg/dl (2.8mmol/L) or >400mg/dl (22.2mmol/L); Baseline platelet count <50×109/L; Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications; Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test; Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders). Imaging Exclusion Criteria: CT or MR evidence of acute intracranial hemorrhage (the presence of microbleeds on MRI is allowed); Midline shift or herniation, mass effect with effacement of the ventricles; Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the 4-th ventricle; Complete bilateral thalamic infarction on CT or MRI; Inability to endovascular treatment due to Excessive tortuosity, variation, or dissection of the artery; Subjects with occlusions in both intracranial vertebral arteries; Subjects with occlusions in both anterior and posterior circulation; Evidence of intracranial tumor (except small meningioma).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contact aspiration first line thrombectomy<br>Patients will have the mechanical thrombectomy by first-line contact aspiration | Procedure: Contact aspiration Thrombectomy<br>* Contant aspiration is an approach that utilizes the advantages of large-bore aspiration catheters that can be easily tracked and introduced into the cerebral circulation to directly remove the thrombus via negative pressure aspiration.<br>|
| Active Comparator: Stent retriever first line thrombectomy<br>Patients will have the mechanical thrombectomy by first-line stent retriever | Procedure: Stent retriever thrombectomy<br>* Stent retriever thrombetomy is an approach that utilize sself-expandable stent for thrombectomy. The stent retriever is expanded to capture the thrombus, which immediately may restore blood flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of first pass effect (FPE) | [The definition of FPE: 1) single pass/use of the device; 2) complete revascularization of the large vessel occlusion and its downstream territory (eTICI 3); 3) no use of rescue therapy.] | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete reperfusion (eTICI 3) after first-line thrombectomy strategy and at the end of endovascular procedure | eTICI： grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2 grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion) | 24 hours | 
| Rate of near to complete reperfusion (eTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure | eTICI： grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2 grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion) | 24 hours | 
| Rate of successful reperfusion (eTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure | eTICI： grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2 grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion) | 24 hours | 
| Rate of Arterial Occlusive Lesion (AOL) recanalization score 3 after first-line thrombectomy strategy and at the end of endovascular procedure | AOL recanalization score is evaluated between 0 to 3: 0 indicates no recanalization of the primary occlusive lesion; indicates incomplete or partial recanalization of the primary occlusive lesion with no distal flow; indicates incomplete or partial recanalization of the primary occlusive lesion with any distal flow; indicates complete recanalization of the primary occlusive with any distal flow. | 24 hours | 
| Groin puncture time to successful reperfusion time (min) | evaluated in minutes | 24 hours | 
| The difference of NIHSS score between 24-hour and baseline | NIHSS (National Institutes of Health Stroke Scale) score is evaluated between 0-42 0 is normal and 42 maximal gravity | 24 hours | 
| Modified Rankin Score (mRS) at 90±14 days (shift analysis) | mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death. | 90 days | 
| Rate of mRS 0-1 at at 90±14 days | mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death. | 90 days | 
| Rate of mRS 0-2 at at 90±14 days | mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death. | 90 days | 
| Rate of mRS 0-3 at at 90±14 days | mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death. | 90 days | 
| Quality of life at 90±14 days assessed by EuroQol 5D-5L scale | EuroQol 5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 90 days | 
| Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification) | Heidelberg Bleeding Classification: Hemorrhagic transformation of infarcted brain tissue 1a HI1 Scattered small petechiae, no mass effect 1b HI2 Confluent petechiae, no mass effect 1c PH1 Hematoma within infarcted tissue, occupying <30%, no substantive mass effect 2 Intracerebral hemorrhage within and beyond infarcted brain tissue PH2 Hematoma occupying 30% or more of the infarcted tissue, with obvious mass effect 3 Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage 3a Parenchymal hematoma remote from infarcted brain tissue 3b Intraventricular hemorrhage 3c Subarachnoid hemorrhage 3d Subdural hemorrhage | 48 hours | 
| Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification) | Heidelberg Bleeding Classification: Hemorrhagic transformation of infarcted brain tissue 1a HI1 Scattered small petechiae, no mass effect 1b HI2 Confluent petechiae, no mass effect 1c PH1 Hematoma within infarcted tissue, occupying <30%, no substantive mass effect 2 Intracerebral hemorrhage within and beyond infarcted brain tissue PH2 Hematoma occupying 30% or more of the infarcted tissue, with obvious mass effect 3 Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage 3a Parenchymal hematoma remote from infarcted brain tissue 3b Intraventricular hemorrhage 3c Subarachnoid hemorrhage 3d Subdural hemorrhage | 48 hours | 
| Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage |  | 24 hours | 
| All cause of mortality at 90±14 days |  | 90 days |