The Safety and Efficacy of Embotrap in Treating Acute Isc... | NCT05667103

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

NCT05667103

Sponsor

Xuanwu Hospital, Beijing

Status

Unknown status

Last Update Posted

Nov 13, 2023Actual

Enrollment

330Estimated

Phase

Not Applicable

Conditions

Stroke
Acute Ischemic Stroke

Interventions

Embotrap stent retriever
Solitaire FR, Trevo stent retriever without inner channel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2023Actual

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Nov 21, 2022

First Submission Date that Met QC Criteria

Dec 26, 2022

First Posted Date

Dec 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2023

Last Update Posted Date

Nov 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

330Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Embotrap stent retriever	Experimental		Device: Embotrap stent retriever
Other stent retriever without endochannel	Active Comparator		Device: Solitaire FR, Trevo stent retriever without inner channel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embotrap stent retriever	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
First-pass successful recanalization rate	mFPE, eTICI≥2b50	intraoperative (After first-pass thrombectomy)
Final successful recanalization rate	mFPE, eTICI≥2b50

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liqun Jiao, Dr.	Contact	13911224991		liqunjiao@sina.cn
Bin Yang, Dr.	Contact	18519271163		yangbin_81@163.com

Overall Officials

Name	Affiliation	Role
Liqun Jiao, Dr.	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital, Capital Medical University.	Recruiting	Beijing		100053	China

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.