Back to resultsA Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion (ANGEL-COAST)
Primary Purpose
Basilar Artery Occlusion, Endovascular Treatment
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Contact aspiration Thrombectomy
Stent retriever thrombectomy
Sponsored by
About this trial
This is an interventional treatment trial for Basilar Artery Occlusion
Eligibility Criteria
Inclusion Criteria: 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. 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).
Sites / Locations
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- Beijing Anzhen HospitalRecruiting
- Beijing Daxing District People's HospitalRecruiting
- Anyang People's HospitalRecruiting
- Zhangzhou Municipal HospitalRecruiting
- Baotou Center HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Contact aspiration first line thrombectomy
Stent retriever first line thrombectomy
Arm Description
Patients will have the mechanical thrombectomy by first-line contact aspiration
Patients will have the mechanical thrombectomy by first-line stent retriever
Outcomes
Primary Outcome Measures
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.]
Secondary Outcome Measures
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)
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)
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)
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.
Groin puncture time to successful reperfusion time (min)
evaluated in minutes
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
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.
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.
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.
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.
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.
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
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
Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage
All cause of mortality at 90±14 days
Full Information
NCT ID
NCT05615038
First Posted
November 7, 2022
Last Updated
November 17, 2022
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05615038
Brief Title
A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basilar Artery Occlusion, Endovascular Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contact aspiration first line thrombectomy
Arm Type
Experimental
Arm Description
Patients will have the mechanical thrombectomy by first-line contact aspiration
Arm Title
Stent retriever first line thrombectomy
Arm Type
Active Comparator
Arm Description
Patients will have the mechanical thrombectomy by first-line stent retriever
Intervention Type
Procedure
Intervention Name(s)
Contact aspiration Thrombectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stent retriever thrombectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of first pass effect (FPE)
Description
[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.]
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Rate of complete reperfusion (eTICI 3) after first-line thrombectomy strategy and at the end of endovascular procedure
Description
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)
Time Frame
24 hours
Title
Rate of near to complete reperfusion (eTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
Description
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)
Time Frame
24 hours
Title
Rate of successful reperfusion (eTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
Description
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)
Time Frame
24 hours
Title
Rate of Arterial Occlusive Lesion (AOL) recanalization score 3 after first-line thrombectomy strategy and at the end of endovascular procedure
Description
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.
Time Frame
24 hours
Title
Groin puncture time to successful reperfusion time (min)
Description
evaluated in minutes
Time Frame
24 hours
Title
The difference of NIHSS score between 24-hour and baseline
Description
NIHSS (National Institutes of Health Stroke Scale) score is evaluated between 0-42 0 is normal and 42 maximal gravity
Time Frame
24 hours
Title
Modified Rankin Score (mRS) at 90±14 days (shift analysis)
Description
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death.
Time Frame
90 days
Title
Rate of mRS 0-1 at at 90±14 days
Description
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death.
Time Frame
90 days
Title
Rate of mRS 0-2 at at 90±14 days
Description
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death.
Time Frame
90 days
Title
Rate of mRS 0-3 at at 90±14 days
Description
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death.
Time Frame
90 days
Title
Quality of life at 90±14 days assessed by EuroQol 5D-5L scale
Description
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.
Time Frame
90 days
Title
Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
Description
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
Time Frame
48 hours
Title
Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
Description
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
Time Frame
48 hours
Title
Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage
Time Frame
24 hours
Title
All cause of mortality at 90±14 days
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Sun, Dr
Phone
13810926284
Email
sxuan@yeah.net
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Yang
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Guo
Facility Name
Beijing Daxing District People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haihua Yang
Facility Name
Anyang People's Hospital
City
Anyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangang Zhang
Facility Name
Zhangzhou Municipal Hospital
City
Zhangzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhuo Chen
Facility Name
Baotou Center Hospital
City
Baotou
State/Province
Neimenggu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changchun Jiang
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion
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