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

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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)

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

Trial contacts and locations

6

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Central trial contact

Xuan Sun, Dr

Data sourced from clinicaltrials.gov

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