Clinical trial NCT03601702: EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke
Official title: Multicentric Observational Prospective Study on the Use of the EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
endovascular treatment
stent retriever device
mechanical thrombectomy
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
Collaborators: name: Neuravi Limited
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Safety: device -related haemorrhages rate showed by CT/MR
timeFrame: 10 days
measure: Efficacy: Restoration of cerebral blood flow at the end of the procedure
timeFrame: 1 day
Secondary outcomes:
measure: Rate of embolisation in new territories
timeFrame: 10 days
measure: Restoration of cerebral flow to achieve mTICI 2b/3 as second line treatment
timeFrame: 1 day
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
Study officials:
References: