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

Multicentric Observational Prospective Study on the Use of the EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Mechanical thrombectomy with EmboTrap ® II Device

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Edoardo Boccardi, MD; Phone Number: 2772 00396444; Email: edoardo.bocccardi@ospedaleniguarda.it
• Study Contact Backup: Name: Luca Valvassori, MD; Phone Number: 2772 00396444; Email: luca.valvassori@gmail.com

Study Locations

• Italy
  • Milano, Italy, 20162
    • Recruiting
    • ASST GOM Niguarda
    • Contact: Edoardo Boccardi, MD; Phone Number: 1 +39026444; Email: edoardo.boccardi@ospedaleniguarda.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry enrolls acute ischemic stroke patients presenting within 12 hours from neurological 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) according to the Instructions For Use

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EmboTrap ® II Device; The study group consists of the patients with acute ischemic stroke from large vessel occlusion treated with EmboTrap ® II Device (Neuravi)	Device: Mechanical thrombectomy with EmboTrap ® II Device; Endovascular treatment with mechanical thrombectomy using EmboTrap ® II Device (Neuravi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: device -related haemorrhages rate showed by CT/MR	Procedure-related mortality rate	10 days
Efficacy: Restoration of cerebral blood flow at the end of the procedure	Restoration of cerebral blood flow	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of embolisation in new territories	Rate of embolisation in new territories	10 days
Restoration of cerebral flow to achieve mTICI 2b/3 as second line treatment	Efficacy of the device Embotrap II Clot Retriever (Neuravi), as second line treatment in the restoration of cerebral flow to achieve mTICI 2b/3	1 day

Collaborators and Investigators

• Sponsor: Niguarda Hospital
• Collaborators: Neuravi Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 15, 2024

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: endovascular treatment; acute ischemic stroke; mechanical thrombectomy; stent retriever device
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: REGISTRAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators' meeting
• IPD Sharing Time Frame: Each six months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No