Health TrialsbyHealthPanel

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

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Informed consent not given

Extracranial or tandem occlusion

Trial 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Mechanical thrombectomy with EmboTrap ® II Device

    Device

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: EmboTrap ® II Device1 intervention

Trial outcomes

Primary outcomes

1

Safety: device -related haemorrhages rate showed by CT/MR

Procedure-related mortality rate

Time frame
10 days
2

Efficacy: Restoration of cerebral blood flow at the end of the procedure

Restoration of cerebral blood flow

Time frame
1 day

Secondary outcomes

1

Rate of embolisation in new territories

Rate of embolisation in new territories

Time frame
10 days
2

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

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Niguarda Hospital

Lead sponsor

Neuravi Limited

Collaborator

Source ClinicalTrials.gov
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