Back to resultsThe Safety and Efficacy of Embotrap Ⅱ in Treating Patients With Acute Ischemic Stroke
Primary Purpose
Stroke, Acute Ischemic Stroke
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Embotrap Ⅱ
Solitaire FR, Trevo stent retriever without inner channel
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Embotrap Ⅱ, Acute ischemic stroke, Mechanical thrombectomy
Eligibility Criteria
Inclusion Criteria: Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis. Premorbid mRS 0-2 Ages 18-80 years NIHSS ≥6 at admission The time from onset to groin puncture ≤ 24 hours ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP) Informed consent approved by patients or acceptable patient surrogate. Exclusion Criteria: Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory). Severe allergy to contrast media allergy and nitinol Refractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg) Platelet count < 30 x 10^9 / L Coagulopathy history or hemorrhage disorders disease Concurrent participation in a study involving an investigational drug or device that would impact the current study Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders Pregnant or lactating women Anticipated life expectancy < 6 months Patients without a legally authorized representative to sign the consent form For other reasons, the researchers believe that the patient is not suitable for enrollment
Sites / Locations
- Xuanwu Hospital, Capital Medical University.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Embotrap Ⅱ
Other stent retriever without endochannel
Arm Description
Outcomes
Primary Outcome Measures
First-pass complete recanalization rate
FPE, eTICI≥2c
Secondary Outcome Measures
First-pass successful recanalization rate
mFPE, eTICI≥2b50
Final successful recanalization rate
mFPE, eTICI≥2b50
Final complete recanalization rate
FPE, eTICI≥2c
90-day favorable outcome rate
Modified Rankin scale (mRS), the scale runs from 0 to 6, running from perfect health without symptoms to death. 90-day favorable outcome is identified as mRS 0-2.
The improvement of the NIHSS scores 24 hours after surgery
National Institutes of Health Stroke Scale (NIHSS)
The improvement of the NIHSS scores 5-7 days after surgery or at discharge
National Institutes of Health Stroke Scale (NIHSS)
The rescue therapy rate
The rate of rescue therapy, such as balloon dilation, stent implantation, and intra-arterial thrombolysis.
FFR after 5 minutes of mechanical thrombectomy
Fractional flow reserve (FFR)
Full Information
NCT ID
NCT05667103
First Posted
November 21, 2022
Last Updated
January 27, 2023
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05667103
Brief Title
The Safety and Efficacy of Embotrap Ⅱ in Treating Patients With Acute Ischemic Stroke
Official Title
The Safety and Efficacy of Embotrap Ⅱ in Treating Patients With Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of EmboTrap II with other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.
Detailed Description
AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, EmboTrap II has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed EmboTrap II can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap II was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap Ⅱ with other stent retrievers without inner channel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic Stroke
Keywords
Embotrap Ⅱ, Acute ischemic stroke, Mechanical thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a multicenter, parallel cohort study. The patients with acute middle cerebral artery occlusion were divided into Embotrap Ⅱ group and control group at a ratio of 1:1 to receive mechanical thrombectomy. The patients in control group will receive thrombectomy using stent retriever without inner channel approved by FDA or CFDA. Several aspects such as first-pass recanalization rate, the successful recanalization rate, and mRS score at 90 days will be compared between the two groups.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embotrap Ⅱ
Arm Type
Experimental
Arm Title
Other stent retriever without endochannel
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Embotrap Ⅱ
Intervention Description
Embotrap Ⅱ has a novel design of an open outer cage for clot capture and a closed inner channel for clot stabilization, with great thrombus fixation and anti-escape ability, to improve the successful recanalization rate and good prognosis of patients.
Intervention Type
Device
Intervention Name(s)
Solitaire FR, Trevo stent retriever without inner channel
Intervention Description
Other stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or CFDA.
Primary Outcome Measure Information:
Title
First-pass complete recanalization rate
Description
FPE, eTICI≥2c
Time Frame
intraoperative (After first-pass thrombectomy)
Secondary Outcome Measure Information:
Title
First-pass successful recanalization rate
Description
mFPE, eTICI≥2b50
Time Frame
intraoperative (After first-pass thrombectomy)
Title
Final successful recanalization rate
Description
mFPE, eTICI≥2b50
Time Frame
intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
Title
Final complete recanalization rate
Description
FPE, eTICI≥2c
Time Frame
intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
Title
90-day favorable outcome rate
Description
Modified Rankin scale (mRS), the scale runs from 0 to 6, running from perfect health without symptoms to death. 90-day favorable outcome is identified as mRS 0-2.
Time Frame
90-days (±14days)
Title
The improvement of the NIHSS scores 24 hours after surgery
Description
National Institutes of Health Stroke Scale (NIHSS)
Time Frame
24 hours after surgery
Title
The improvement of the NIHSS scores 5-7 days after surgery or at discharge
Description
National Institutes of Health Stroke Scale (NIHSS)
Time Frame
5-7 days after surgery or at discharge, whichever came first
Title
The rescue therapy rate
Description
The rate of rescue therapy, such as balloon dilation, stent implantation, and intra-arterial thrombolysis.
Time Frame
During procedure time
Title
FFR after 5 minutes of mechanical thrombectomy
Description
Fractional flow reserve (FFR)
Time Frame
5 minutes after successful vessel recanalization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.
Premorbid mRS 0-2
Ages 18-80 years
NIHSS ≥6 at admission
The time from onset to groin puncture ≤ 24 hours
ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP)
Informed consent approved by patients or acceptable patient surrogate.
Exclusion Criteria:
Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory).
Severe allergy to contrast media allergy and nitinol
Refractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
Platelet count < 30 x 10^9 / L
Coagulopathy history or hemorrhage disorders disease
Concurrent participation in a study involving an investigational drug or device that would impact the current study
Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy
Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders
Pregnant or lactating women
Anticipated life expectancy < 6 months
Patients without a legally authorized representative to sign the consent form
For other reasons, the researchers believe that the patient is not suitable for enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, Dr.
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University.
City
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of Embotrap Ⅱ in Treating Patients With Acute Ischemic Stroke
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