7 results
The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…
1) The BioNIR is non-inferior to the Resolute for the primary clinical endpoint of target lesion failure (TLF) (defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR) at 12 months2/ The BioNIR is non-inferior to…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
The BioNIR is non-inferior to the Resolute for the primary angiographic of in-stent late loss at 6 months
Number of patients with >=80% reduction of VT burden, i.e., any ICD-treated or highly-symptomatic VT episodes, at one year after STAR compared to the year before (including VTs during the 8 week-blanking period). Efficacy parameters will be…
Primary Objective: * To evaluate the ability to concentrate the radiotracer within the prostate gland improving the evaluation of the primary prostate tumor. Secondary Objective(s): * To evaluate the PET/CT imaging characteristics of transcatheter,…
The primary study objective is to compare: - Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. The secondary objectives are to assess: - Impact on patient treatment/management. - Per-region detection rate of 18F-DCFPyL…