The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke; Stroke
• Interventions: Device: Solitaire FR, Trevo stent retriever without inner channel; Device: Embotrap stent retriever

• Registration Number: NCT05667103
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2022-12-28
• Study Start: 2023-01-15
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Other stent retriever without endochannel	Solitaire FR, Trevo stent retriever without inner channel	-
Embotrap stent retriever	Embotrap stent retriever	-

Primary Outcome Measures

Name	Time	Method
First-pass complete recanalization rate	intraoperative (After first-pass thrombectomy)	FPE, eTICI≥2c

Secondary Outcome Measures

Name	Time	Method
90-day favorable outcome rate	90-days (±14days)	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.
Final complete recanalization rate	intraoperative (Final Digital Subtraction Angiography (DSA) during operation)	FPE, eTICI≥2c
The improvement of the NIHSS scores 24 hours after surgery	24 hours after surgery	National Institutes of Health Stroke Scale (NIHSS)
The rescue therapy rate	During procedure time	The rate of rescue therapy, such as balloon dilation, stent implantation, and intra-arterial thrombolysis.
Final successful recanalization rate	intraoperative (Final Digital Subtraction Angiography (DSA) during operation)	mFPE, eTICI≥2b50
First-pass successful recanalization rate	intraoperative (After first-pass thrombectomy)	mFPE, eTICI≥2b50
The improvement of the NIHSS scores 5-7 days after surgery or at discharge	5-7 days after surgery or at discharge, whichever came first	National Institutes of Health Stroke Scale (NIHSS)
FFR after 5 minutes of mechanical thrombectomy	5 minutes after successful vessel recanalization.	Fractional flow reserve (FFR)

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University.; 🇨🇳 Beijing, China