Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System
Megadott ok: Sponsor decided to terminate study early solely due to slow enrollment.
Key facts
- Where
- New Haven, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Yale UniversityNew Haven, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Silk Road Medical
- Trial code
- NCT04881162
- Record updated
- 2025. január 17.
- Original description
Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.Read full original descriptionShow less
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.
Inclusion: 1. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices); Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments; Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture.
Exclusion: 1. Significant disease of the ipsilateral common carotid artery on routine CTA; Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS; Any active or recent hemorrhage within the past 30 days; Embolectomy contraindications; Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5; IV tPA has been or is being administered; Last known well > 24 hours ago.