2 results
Approved WMOCompleted
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
Approved WMOCompleted
Primary Study Objectives:Safety objective: assessment of procedure related mortality up to 30 days post-procedure.Performance objective: demonstration of the ability of Valvosoft to modify the structure of the calcified valve leaflets to improve…