EmboTrap II clot retriever for re-opening blocked brain arteries in acute ischemic stroke
Multicentric Observational Prospective Study on the Use of the EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke
This registry will see if the EmboTrap II clot retriever can safely and effectively reopen large blocked brain arteries in adults with acute ischemic stroke treated within 12 hours.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT03601702 on ClinicalTrials.gov |
What this trial studies
Registrap is a prospective, single-arm, multicenter observational registry enrolling at least 100 consecutive patients with large-vessel occlusion who are treated with the CE‑marked EmboTrap II device as first intention. Participating European neurointerventional centers are required to have prior EmboTrap II experience and a high annual stroke procedure volume, and treatments follow the device Instructions for Use. A screening log will capture all thrombectomy cases during enrollment to document device selection and potential operator selection bias. Clinical, imaging, procedural, and safety outcomes are recorded prospectively to characterize real‑world device performance within 12 hours of symptom onset.
Who should consider this trial
Good fit: Ideal candidates are adults with anterior or posterior proximal large‑vessel occlusions (up to A1, M1, dominant M2, P1), ASPECTS ≥ 6, evidence of mismatch or good collaterals on imaging, groin puncture within 12 hours, and informed consent to be treated with EmboTrap II.
Not a fit: Patients with extracranial or tandem occlusions, poor baseline imaging (low ASPECTS or unfavorable collaterals), presentation beyond 12 hours, or who cannot receive or consent to EmboTrap II thrombectomy are unlikely to benefit from this registry.
Why it matters
Potential benefit: If successful, results could increase confidence in using EmboTrap II to reopen blocked arteries and improve recovery after large‑vessel stroke.
How similar studies have performed: Mechanical thrombectomy with stent retrievers has strong randomized-trial support for large‑vessel stroke, and device‑specific registries and studies of EmboTrap II and comparable devices have reported favorable recanalization and safety outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- ASST GOM Niguarda — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Edoardo Boccardi, MD
- Email: edoardo.bocccardi@ospedaleniguarda.it
- Phone: 00396444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.