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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667103
• Other study ID #: Embotrap
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Liqun Jiao, Dr.
• Phone: 13911224991
• Email: liqunjiao[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-pass complete recanalization rate	FPE, eTICI=2c	intraoperative (After first-pass thrombectomy)
Secondary	First-pass successful recanalization rate	mFPE, eTICI=2b50	intraoperative (After first-pass thrombectomy)
Secondary	Final successful recanalization rate	mFPE, eTICI=2b50	intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
Secondary	Final complete recanalization rate	FPE, eTICI=2c	intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
Secondary	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)
Secondary	The improvement of the NIHSS scores 24 hours after surgery	National Institutes of Health Stroke Scale (NIHSS)	24 hours after surgery
Secondary	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
Secondary	The rescue therapy rate	The rate of rescue therapy, such as balloon dilation, stent implantation, and intra-arterial thrombolysis.	During procedure time
Secondary	FFR after 5 minutes of mechanical thrombectomy	Fractional flow reserve (FFR)	5 minutes after successful vessel recanalization.