4 results
The primary safety endpoint is to evaluate a 30-day major adverse event (MAE) rate, where MAE is a composite of the following device- or procedure-related events: * All-cause mortality* Stroke* Life-threatening bleeding (MVARC scale)* Major vascular…
To assess the safety and efficacy of the FANTOM ENCORE sirolimus-eluting BRS.
Primary Objectives1) To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) in first line recurrent / metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects, treated…
Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…