A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion (ANGEL-COAST)

Capital Medical University

Status: Active, not recruiting

Conditions: Basilar Artery Occlusion; Endovascular Treatment

Treatments: Procedure: Stent retriever thrombectomy; Procedure: Contact aspiration Thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05615038

KY2022-123-03

Details and patient eligibility

About

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

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

Contact aspiration first line thrombectomy

Experimental group

Description:

Patients will have the mechanical thrombectomy by first-line contact aspiration

Treatment:

Procedure: Contact aspiration Thrombectomy

Stent retriever first line thrombectomy

Active Comparator group

Description:

Patients will have the mechanical thrombectomy by first-line stent retriever

Treatment:

Procedure: Stent retriever thrombectomy