Ongoing Terumo Neuro Clinical Trial
CONFIDENCE: A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and effectiveness of Roadsaver™ carotid stent device used in con-junction with the Nanoparasol™ embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy. The primary endpoint will consist of the proportion of patients who have a stroke, death or MI reported within 1 month from the index procedure or ipsilateral stroke within 12 months of the index procedure.
Ongoing Terumo Neuro Clinical Trial
SOFAST: This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE) post-market study with two cohorts. The primary objective of Cohort I is to determine the proportion of subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA™ Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke in the anterior circulation based on collection of real-world evidence data. The objective of Cohort II is to evaluate standard outcomes such as successful revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time and procedure related major neurological complications based on collection of real-world evidence data.
No information available
Clinical Education
Terumo Neuro participates in global clinical studies in order to establish the safety and efficacy of the products we develop, sell and license. Research provides real world data and experience that drives the adoption of emerging technologies. Please see below for information on our ongoing and completed clinical trials.