5 results
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 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…
Primary: To collect long-term safety data.Secondary objectives: To collect long-term efficacy data (LDL-C).
Primary Objective: To evaluate the effect of treatment with AMG 145, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs…
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…