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

NCT05615038 | Active Not Recruiting DMC

• 1 other identifier: KY2022-123-03
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Basilar Artery Occlusion; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• Rate of first pass effect (FPE)

  \[The definition of FPE: 1) single pass/use of the device; 2)recanalization of the large vessel occlusion to eTICI 2C/3;3) no use of rescue therapy.\]

  24 hours

Secondary Outcomes (15)

• Rate of complete reperfusion (eTICI 3) after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Rate of near to complete reperfusion (eTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Rate of successful reperfusion (eTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Rate of Arterial Occlusive Lesion (AOL) recanalization score 3 after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Groin puncture time to successful reperfusion time (min)

  24 hours

Study Arms (2)

Contact aspiration first line thrombectomy

EXPERIMENTAL

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

Procedure: Contact aspiration Thrombectomy

Stent retriever first line thrombectomy

ACTIVE COMPARATOR

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

Procedure: Stent retriever thrombectomy

Interventions

Contact aspiration Thrombectomy PROCEDURE

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.

Contact aspiration first line thrombectomy

Stent retriever thrombectomy PROCEDURE

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.

Stent retriever first line thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years;
• Acute basilar artery occlusion confirmed by CTA/MRA/DSA;
• Last known well to puncture time≤24 hours;
• pc-ASPECTS score≥6 points;
• Baseline NIHSS score≥10 points;
• Consent to endovascular treatment;
• Informed consent signed.

You may not qualify if:

• Baseline mRS≥3 points;
• Known or suspected severe basilar artery stenosis (\>70%) or chronic occlusion based on history, imaging, or clinical manifestations;
• Refractory hypertension that is difficult to be controlled by drugs (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
• Genetic or acquired hemorrhagic tendency, coagulation factor deficiency or on anticoagulant therapy and International Normalized Ratio (INR) \> 3.0;
• Laboratory tests: baseline blood glucose \<50mg/dl (2.8mmol/L) or \>400mg/dl (22.2mmol/L); Baseline platelet count \<50×109/L;
• Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
• Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
• 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).
• CT or MR evidence of acute intracranial hemorrhage (the presence of microbleeds on MRI is allowed);
• Midline shift or herniation, mass effect with effacement of the ventricles;
• Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the 4-th ventricle;
• Complete bilateral thalamic infarction on CT or MRI;
• Inability to endovascular treatment due to Excessive tortuosity, variation, or dissection of the artery;
• Subjects with occlusions in both intracranial vertebral arteries;
• Subjects with occlusions in both anterior and posterior circulation;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (6)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Beijing Daxing District People's Hospital

Beijing, Beijing Municipality, China

Location

Anyang People's Hospital

Anyang, Henan, China

Location

Zhangzhou Municipal Hospital

Zhangzhou, Henan, China

Location

Baotou Center Hospital

Baotou, Neimenggu, China

Location

Related Publications (1)

• Xuan S, Yang M, Sun D, Song L, Gao F, Mo D, Ma N, Pan Y, Liu L, Zhao X, Wang Y, Wang Y, Nogueira R, Miao Z. Contact aspiration versus stent retriever thrombectomy for acute basilar artery occlusion (ANGEL-COAST): rationale and design of a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Stroke Vasc Neurol. 2025 Oct 28:svn-2025-004232. doi: 10.1136/svn-2025-004232. Online ahead of print.

  PMID: 41151802 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Neurology

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: November 7, 2022
• Primary Completion: February 21, 2025
• Study Completion: June 30, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-02

Locations

CN (6)