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

Last updated: November 8, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Occlusions

Treatment

Embotrap stent retriever

Solitaire FR, Trevo stent retriever without inner channel

Clinical Study ID

NCT05667103
Embotrap
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treatedwith 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

Exclusion Criteria:

  1. Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral arteryterritory).
  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 thatwould 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 oremotional 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 forenrollment

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Embotrap stent retriever
Phase:
Study Start date:
January 15, 2023
Estimated Completion Date:
July 01, 2024

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University.

    Beijing, 100053
    China

    Active - Recruiting

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