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

The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Acute Ischemic Stroke
• Intervention / Treatment: Device: Embotrap stent retriever; Device: Solitaire FR, Trevo stent retriever without inner channel

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 Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liqun Jiao, Dr.; Phone Number: 13911224991; Email: liqunjiao@sina.cn
• Study Contact Backup: Name: Bin Yang, Dr.; Phone Number: 18519271163; Email: yangbin_81@163.com

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital, Capital Medical University.
    • Contact: Liqun Jiao, Dr.; Phone Number: 13911224991; Email: liqunjiao@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Other stent retriever without endochannel	Device: Solitaire FR, Trevo stent retriever without inner channel; Other stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or NMPA.
Experimental: Embotrap stent retriever	Device: Embotrap stent retriever; Embotrap 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-pass complete recanalization rate	FPE, eTICI≥2c	intraoperative (After first-pass thrombectomy)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liqun Jiao, Dr., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 26, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; Mechanical thrombectomy; Stent retriever; Embotrap
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: Embotrap

Drug and device information, study documents

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