Basilar Artery Occlusion, Endovascular Treatment
Conditions
Brief summary
Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion.
Interventions
PROCEDUREContact aspiration Thrombectomy
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.
PROCEDUREStent retriever thrombectomy
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years; 2. Acute basilar artery occlusion confirmed by CTA/MRA/DSA; 3. Last known well to puncture time≤24 hours; 4. pc-ASPECTS score≥6 points; 5. Baseline NIHSS score≥10 points; 6. Consent to endovascular treatment; 7. Informed consent signed. Clinical
Exclusion criteria
1. Baseline mRS≥3 points; 2. Known or suspected severe basilar artery stenosis (\>70%) or chronic occlusion based on history, imaging, or clinical manifestations; 3. Refractory hypertension that is difficult to be controlled by drugs (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) 4. Genetic or acquired hemorrhagic tendency, coagulation factor deficiency or on anticoagulant therapy and International Normalized Ratio (INR) \> 3.0; 5. Laboratory tests: baseline blood glucose \<50mg/dl (2.8mmol/L) or \>400mg/dl (22.2mmol/L); Baseline platelet count \<50×109/L; 6. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications; 7. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test; 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of first pass effect (FPE) | 24 hours | \[The definition of FPE: 1) single pass/use of the device; 2)recanalization of the large vessel occlusion to eTICI 2C/3;3) no use of rescue therapy.\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause of mortality at 90±14 days | 90 days | — |
| Rate of complete reperfusion (eTICI 3) after first-line thrombectomy strategy and at the end of endovascular procedure | 24 hours | 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) |
| Rate of near to complete reperfusion (eTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure | 24 hours | 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) |
| Rate of successful reperfusion (eTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure | 24 hours | 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) |
| Rate of Arterial Occlusive Lesion (AOL) recanalization score 3 after first-line thrombectomy strategy and at the end of endovascular procedure | 24 hours | AOL recanalization score is evaluated between 0 to 3: 0 indicates no recanalization of the primary occlusive lesion; 1. indicates incomplete or partial recanalization of the primary occlusive lesion with no distal flow; 2. indicates incomplete or partial recanalization of the primary occlusive lesion with any distal flow; 3. indicates complete recanalization of the primary occlusive with any distal flow. |
| Groin puncture time to successful reperfusion time (min) | 24 hours | evaluated in minutes |
| The difference of NIHSS score between 24-hour and baseline | 24 hours | NIHSS (National Institutes of Health Stroke Scale) score is evaluated between 0-42 0 is normal and 42 maximal gravity |
| Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage | 24 hours | — |
| Rate of mRS 0-1 at at 90±14 days | 90 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. |
| Rate of mRS 0-2 at at 90±14 days | 90 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. |
| Rate of mRS 0-3 at at 90±14 days | 90 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. |
| Quality of life at 90±14 days assessed by EuroQol 5D-5L scale | 90 days | 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. |
| Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification) | 48 hours | Heidelberg Bleeding Classification: 1. 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 |
| Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification) | 48 hours | Heidelberg Bleeding Classification: 1. 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 |
| Modified Rankin Score (mRS) at 90±14 days (shift analysis) | 90 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. |
Countries
China
Outcome results
None listed