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

NCT05667103 | Unknown

• 1 other identifier: Embotrap
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Acute Ischemic Stroke

Keywords

Embotrap; Acute ischemic stroke; Mechanical thrombectomy; Stent retriever

Outcome Measures

Primary Outcomes (1)

• First-pass complete recanalization rate

  FPE, eTICI≥2c

  intraoperative (After first-pass thrombectomy)

Secondary Outcomes (8)

• First-pass successful recanalization rate

  intraoperative (After first-pass thrombectomy)

• Final successful recanalization rate

  intraoperative (Final Digital Subtraction Angiography (DSA) during operation)

• Final complete recanalization rate

  intraoperative (Final Digital Subtraction Angiography (DSA) during operation)

• 90-day favorable outcome rate

  90-days (±14days)

• The improvement of the NIHSS scores 24 hours after surgery

  24 hours after surgery

Study Arms (2)

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

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.

Embotrap stent retriever

Solitaire FR, Trevo stent retriever without inner channel DEVICE

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

Other stent retriever without endochannel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liqun Jiao, Dr.

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqun Jiao, Dr.

CONTACT

13911224991; liqunjiao@sina.cn

Bin Yang, Dr.

CONTACT

18519271163; yangbin_81@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 28, 2022
• Study Start: January 15, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2022-11

Locations

CN (1)