6 results
Evaluate the safety and performance of the Virtue* Sirolimus Eluting Balloon for the treatment of in-stent restenosis (ISR) in native coronary arteries.
• To estimate the difference in the efficacy and safety of RAD001 10 mg p.o. daily dose in combination with bevacizumab 10 mg/kg administered intravenously every two weeks for first-line treatment of patients with metastatic carcinoma of the kidney…
The primary objective of this randomized trial is to assess the Safety and efficacy of the Genous Bio-engineered R Stent* pre-dilated with paclitaxel-eluting balloon (Pantera®) versus the Genous Bio-engineered R Stent* pre-dilated with non drug…
The purpose of this study is to evaluate the implant procedure and feasibility of the Model 20066 LV lead. The proposed Model 20066 study will provide data to assess the safety and feasibility of the Model 20066 fixation concept. It is also expected…
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV lead (Model 4798) in patients indicated for a de novo LV lead implant. This will be assessed through primary safety and primary…
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…