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

Endovascular Treatment Clinical Trial

— ANGEL-COAST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615038
• Other study ID #: KY2022-123-03
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: Beijing Tiantan Hospital
• Contact: Xuan Sun, Dr
• Phone: 13810926284
• Email: sxuan[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Basilar Artery Occlusion
• Endovascular Treatment

Intervention

Procedure:
• Contact aspiration Thrombectomy
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 thrombectomy
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.

Locations

Country	Name	City	State
China	Anyang People's Hospital	Anyang	Henan
China	Baotou Center Hospital	Baotou	Neimenggu
China	Beijing Anzhen Hospital	Beijing	Beijing
China	Beijing Daxing District People's Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Zhangzhou Municipal Hospital	Zhangzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of first pass effect (FPE)	[The definition of FPE: 1) single pass/use of the device; 2) complete revascularization of the large vessel occlusion and its downstream territory (eTICI 3); 3) no use of rescue therapy.]	24 hours
Secondary	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)	24 hours
Secondary	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)	24 hours
Secondary	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)	24 hours
Secondary	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.	24 hours
Secondary	Groin puncture time to successful reperfusion time (min)	evaluated in minutes	24 hours
Secondary	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	24 hours
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	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	48 hours
Secondary	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	48 hours
Secondary	Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage		24 hours
Secondary	All cause of mortality at 90±14 days		90 days