Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
338
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.
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
Anyang People's Hospital
Anyang, Henan, China
Rate of first pass effect (FPE)
\[The definition of FPE: 1) single pass/use of the device; 2)recanalization of the large vessel occlusion to eTICI 2C/3;3) no use of rescue therapy.\]
Time frame: 24 hours
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)
Time frame: 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)
Time frame: 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)
Time frame: 24 hours
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Zhangzhou Municipal Hospital
Zhangzhou, Henan, China
Baotou Center Hospital
Baotou, Neimenggu, China
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; 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.
Time frame: 24 hours
Groin puncture time to successful reperfusion time (min)
evaluated in minutes
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days
Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
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
Time frame: 48 hours
Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
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
Time frame: 48 hours
Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage
Time frame: 24 hours
All cause of mortality at 90±14 days
Time frame: 90 days