Clinical trial NCT05667103: The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients
Official title: The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Acute Ischemic Stroke
Keywords: Embotrap
Acute ischemic stroke
Mechanical thrombectomy
Stent retriever
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicenter, parallel cohort study. The patients with acute middle cerebral artery occlusion were divided into Embotrap 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 NMPA. 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.
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to 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 stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever 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 stent retriever 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 stent retriever with other stent retrievers without inner channel.

Eligibility criteria: Inclusion Criteria:

1. Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.
2. Premorbid mRS 0-2
3. Ages 18-80 years
4. NIHSS ≥6 at admission
5. The time from onset to groin puncture ≤ 24 hours
6. ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP)
7. Informed consent approved by patients or acceptable patient surrogate.

Exclusion Criteria:

1. 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).
2. Severe allergy to contrast media allergy and nitinol
3. Refractory hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg)
4. Platelet count \< 30 x 10\^9 / L
5. Coagulopathy history or hemorrhage disorders disease
6. Concurrent participation in a study involving an investigational drug or device that would impact the current study
7. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy
8. Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders
9. Pregnant or lactating women
10. Anticipated life expectancy \< 6 months
11. Patients without a legally authorized representative to sign the consent form
12. For other reasons, the researchers believe that the patient is not suitable for enrollment

Primary outcomes:
measure: First-pass complete recanalization rate
timeFrame: intraoperative (After first-pass thrombectomy)
Secondary outcomes:
measure: First-pass successful recanalization rate
timeFrame: intraoperative (After first-pass thrombectomy)
measure: Final successful recanalization rate
timeFrame: intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
measure: Final complete recanalization rate
timeFrame: intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
measure: 90-day favorable outcome rate
timeFrame: 90-days (±14days)
measure: The improvement of the NIHSS scores 24 hours after surgery
timeFrame: 24 hours after surgery
measure: The improvement of the NIHSS scores 5-7 days after surgery or at discharge
timeFrame: 5-7 days after surgery or at discharge, whichever came first
measure: The rescue therapy rate
timeFrame: During procedure time
measure: FFR after 5 minutes of mechanical thrombectomy
timeFrame: 5 minutes after successful vessel recanalization.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University.
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liqun Jiao, Dr.
role: PRINCIPAL_INVESTIGATOR
References: