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

NCT ID: NCT05667103

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-07-01

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.

Conditions

Stroke; Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Embotrap stent retriever

Group Type: EXPERIMENTAL

Embotrap stent retriever

Intervention Type: DEVICE

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.

Other stent retriever without endochannel

Group Type: ACTIVE_COMPARATOR

Solitaire FR, Trevo stent retriever without inner channel

Intervention Type: DEVICE

Other stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or NMPA.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liqun Jiao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University.

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Liqun Jiao, Dr.

Role: CONTACT

liqunjiao@sina.cn

13911224991

Bin Yang, Dr.

Role: CONTACT

yangbin_81@163.com

18519271163

Facility Contacts

Liqun Jiao, Dr.

Role: primary

liqunjiao@sina.cn

13911224991

Other Identifiers

Embotrap

Identifier Type: -

Identifier Source: org_study_id