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

NCT03601702 | Recruiting DMC

• 1 other identifier: REGISTRAP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; endovascular treatment; stent retriever device; mechanical thrombectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Rate of embolisation in new territories

  10 days

• Restoration of cerebral flow to achieve mTICI 2b/3 as second line treatment

  1 day

Study Arms (1)

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

Interventions

Mechanical thrombectomy with EmboTrap ® II Device DEVICE

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

EmboTrap ® II Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Informed consent not given
• Extracranial or tandem occlusion

Sponsors & Collaborators

• Niguarda Hospital: lead
• Neuravi Limited: collaborator

Study Sites (1)

ASST GOM Niguarda

Milan, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Edoardo Boccardi, MD

CONTACT

00396444; edoardo.bocccardi@ospedaleniguarda.it

Luca Valvassori, MD

CONTACT

00396444; luca.valvassori@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: July 26, 2018
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Each six months

Locations

IT (1)