EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Device: Mechanical thrombectomy with EmboTrap ® II Device
- Registration Number
- NCT03601702
- Lead Sponsor
- Niguarda Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EmboTrap ® II Device Mechanical thrombectomy with EmboTrap ® II Device The study group consists of the patients with acute ischemic stroke from large vessel occlusion treated with EmboTrap ® II Device (Neuravi)
- Primary Outcome Measures
Name Time Method Safety: device -related haemorrhages rate showed by CT/MR 10 days Procedure-related mortality rate
Efficacy: Restoration of cerebral blood flow at the end of the procedure 1 day Restoration of cerebral blood flow
- Secondary Outcome Measures
Name Time Method Restoration of cerebral flow to achieve mTICI 2b/3 as second line treatment 1 day Efficacy of the device Embotrap II Clot Retriever (Neuravi), as second line treatment in the restoration of cerebral flow to achieve mTICI 2b/3
Rate of embolisation in new territories 10 days Rate of embolisation in new territories
Trial Locations
- Locations (1)
ASST GOM Niguarda
🇮🇹Milano, Italy