Basilar Artery OcclusionANGEL-COASTNCT05615038
A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion
A study testing Contact aspiration Thrombectomy and Stent retriever thrombectomy in people with Basilar Artery Occlusion and Endovascular Treatment, run by Beijing Tiantan Hospital at 6 sites in China.
Trial summary
Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Artery Occlusion, Endovascular Treatment
- What is being tested?
- Contact aspiration Thrombectomy and Stent retriever thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 6 sitesChina
- Study dates
- 7 Nov 2022to 30 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Informed consent signed.
- Clinical Exclusion Criteria:
- 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).
- Imaging Exclusion Criteria:
- 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;
- Evidence of intracranial tumor (except small meningioma).
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Anyang People's Hospital
Anyang, Henan
Baotou Center Hospital
Baotou, Neimenggu
Beijing Anzhen Hospital
Beijing, Beijing Municipality
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Zhangzhou Municipal Hospital
Zhangzhou, Henan
About this study
Official title: A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion: A Multicentre, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial
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
- Being tested
- Contact aspiration Thrombectomy, Stent retriever thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact aspiration ThrombectomyProcedure or surgery
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 thrombectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Contact aspiration first line thrombectomy | Experimental | Patients will have the mechanical thrombectomy by first-line contact aspiration Receives: Procedure: Contact aspiration Thrombectomy |
| Stent retriever first line thrombectomy | Active comparator | Patients will have the mechanical thrombectomy by first-line stent retriever Receives: Procedure: Stent retriever thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.]
Measured: 24 hours
Secondary outcomes (15)
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)
Measured: 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)
Measured: 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)
Measured: 24 hours
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;
- indicates incomplete or partial recanalization of the primary occlusive lesion with no distal flow;
- indicates incomplete or partial recanalization of the primary occlusive lesion with any distal flow;
- indicates complete recanalization of the primary occlusive with any distal flow.
Measured: 24 hours
Groin puncture time to successful reperfusion time (min)
evaluated in minutes
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
Heidelberg Bleeding Classification:
- 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
Measured: 48 hours
Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
Heidelberg Bleeding Classification:
- 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
Measured: 48 hours
Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage
Measured: 24 hours
All cause of mortality at 90±14 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start7 Nov 2022
- Primary completion21 Feb 2025
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basilar Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615038
- Sponsor's protocol ID
- KY2022-123-03
- Acronym
- ANGEL-COAST
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 Jun 29;11(3):381-388. doi: 10.1136/svn-2025-004232.
PubMed 41151802