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

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.

Study Overview

• Status: Recruiting
• Conditions: Basilar Artery Occlusion; Endovascular Treatment
• Intervention / Treatment: Procedure: Contact aspiration Thrombectomy; Procedure: Stent retriever thrombectomy

• Study Type: Interventional
• Enrollment (Anticipated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuan Sun, Dr; Phone Number: 13810926284; Email: sxuan@yeah.net

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Weimin Yang
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Xu Guo
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Daxing District People's Hospital
      • Contact: Haihua Yang
  • Henan
    • Anyang, Henan, China
      • Recruiting
      • Anyang People's Hospital
      • Contact: Jiangang Zhang
    • Zhangzhou, Henan, China
      • Recruiting
      • Zhangzhou Municipal Hospital
  • Neimenggu
    • Baotou, Neimenggu, China
      • Recruiting
      • Baotou Center Hospital
      • Contact: Changchun Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contact aspiration first line thrombectomy; Patients will have the mechanical thrombectomy by first-line contact aspiration	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.
Active Comparator: Stent retriever first line thrombectomy; Patients will have the mechanical thrombectomy by first-line stent retriever	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Groin puncture time to successful reperfusion time (min)	evaluated in minutes	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	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.	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.	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.	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.	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.	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	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	48 hours
Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage		24 hours
All cause of mortality at 90±14 days		90 days

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: KY2022-123-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No