EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke

NCT ID: NCT03601702

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-06-15

Brief Summary

The primary aim of Registrap study is to assess the safety and effectiveness of the EmboTrap®II Clot Retriever device (Neuravi) in patients with acute ischemic stroke from large vessel occlusion.

Detailed Description

Registrap is a prospective, single-arm, multicenter, observational registry of the Embotrap®II Clot Retriever (NEURAVI) open to any Neurointerventional Department in Europe with experience in mechanical thrombectomy with the EmboTrap® II device Clot Retriever (5 cases already done) and a number of stroke procedures/year greater than 30.

The EmboTrap®II Clot Retriever (Neuravi) is CE-marked and represents one of the possible treatment devices, chosen by physicians according to their experience and practice, in acute ischemic stroke treatment.

Being REGISTRAP an observational registry and considering that different approaches and devices are available on the market, the investigators are aware that operators' preferences could represent a selection bias. The Screening Log will collect all the stroke cases treated from each centre during the enrollment period to show the rate of EmboTrap®II Clot Retriever (Neuravi) use over the total cases treated and the reasons for choosing other devices. The registry will enroll at least 100 consecutive patients presenting within 12 hours from symptom onset with a Large Vessel Occlusion (LVO) on CTA or MRA in the Anterior or Posterior Proximal Cerebral Vasculature up to A1, M1, Dominant M2, P1 who will be treated using the EmboTrap®II Clot Retriever (Neuravi) as first intention and used according to the Instructions For Use. The registry objectives are to evaluate the efficacy/safety of the device Embotrap II Clot Retriever(Neuravi), as first line treatment in the restoration of cerebral blood flow in cases of acute ischemic stroke from Large Vessel Occlusion. Efficacy is considered when a "modified Treatment in Cerebral Infarction" (mTICI) score of 2b or greater is achieved in the vessel treated with the (Neuravi). Safety refers to the rate of procedure-related and device-related hemorrhages. Number and severity of hemorrhages will be evaluated considering site and size. The first follow-up control will occur at 1 to 10 days post-procedure, the second at 90 days+/-14 days. In addition to the sample, the patients meeting the inclusion criteria and treated using the EmboTrap®II Clot Retriever (Neuravi) as second intention, will also be included in the study and considered only for a specific secondary endpoint.

Conditions

Acute Ischemic Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EmboTrap ® II Device

The study group consists of the patients with acute ischemic stroke from large vessel occlusion treated with EmboTrap ® II Device (Neuravi)

Mechanical thrombectomy with EmboTrap ® II Device

Intervention Type: DEVICE

Endovascular treatment with mechanical thrombectomy using EmboTrap ® II Device (Neuravi)

Interventions

Mechanical thrombectomy with EmboTrap ® II Device

Endovascular treatment with mechanical thrombectomy using EmboTrap ® II Device (Neuravi)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent Form
• Large Vessel Occlusion on CTA or MRA in the Anterior or Posterior Proximal Cerebral Vasculature up to A1, M1, Dominant M2, P1
• ASPECTS ≥ 6
• Mismatch or good collaterals showed at MR or multiphasic CTA or pCT
• Groin Puncture performed within 12 hours from symptom onset
• Use of EmboTrap® II Revascularization Device (Neuravi) as the first or second line treatment

Exclusion Criteria

• Informed consent not given
• Extracranial or tandem occlusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuravi Limited

INDUSTRY

Sponsor Role: collaborator

Niguarda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ASST GOM Niguarda

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Edoardo Boccardi, MD

Role: CONTACT

edoardo.bocccardi@ospedaleniguarda.it

00396444 ext. 2772

Luca Valvassori, MD

Role: CONTACT

luca.valvassori@gmail.com

00396444 ext. 2772

Facility Contacts

Edoardo Boccardi, MD

Role: primary

edoardo.boccardi@ospedaleniguarda.it

+39026444 ext. 1

Other Identifiers

REGISTRAP

Identifier Type: -

Identifier Source: org_study_id