4 results
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
The objective of this study is to obtain further data on the safety and performance of the Stellarex Balloon in the treatment of lesions in *below the knee* popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in…
The objective of this study is to investigate the safety and effectiveness of different combinations of cancer immunotherapies compared to either Nivolumab or Ipilimumab, as determined by comparing the Overall Response Rate, at 24 weeks in patients…