4 results
To assess angiographic and clinical outcomes after treatment of ISR of a prior BMS in the native coronary system with the Lutonix Catheter
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
The primary objective is to assess the feasibility, safety and efficacy of Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies: Lutonix Catheter before or after BMS
Primary Objective:To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to published data with a conventional valve within a MIS approachSecondary Objectives:To describe short term (30 days) and long term (6 months) clinical safetyTo…