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

Not Applicable

Active, not recruiting

• Conditions: Basilar Artery Occlusion; Endovascular Treatment

• Registration Number: NCT05615038
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Status Verified: 2025-02
• Primary Completion: 2025-02-21
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 338

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 Exclusion Criteria:

1. CT or MR evidence of acute intracranial hemorrhage (the presence of microbleeds on MRI is allowed);
2. Midline shift or herniation, mass effect with effacement of the ventricles;
3. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the 4-th ventricle;
4. Complete bilateral thalamic infarction on CT or MRI;
5. Inability to endovascular treatment due to Excessive tortuosity, variation, or dissection of the artery;
6. Subjects with occlusions in both intracranial vertebral arteries;
7. Subjects with occlusions in both anterior and posterior circulation;
8. Evidence of intracranial tumor (except small meningioma).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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
All cause of mortality at 90±14 days	90 days
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
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.
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.
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 procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage	24 hours

Trial Locations

Locations (6)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Daxing District People's Hospital; 🇨🇳 Beijing, Beijing, China

Anyang People's Hospital; 🇨🇳 Anyang, Henan, China

Zhangzhou Municipal Hospital; 🇨🇳 Zhangzhou, Henan, China

Baotou Center Hospital; 🇨🇳 Baotou, Neimenggu, China