3 results
Approved WMORecruiting
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…
Approved WMOCompleted
Evaluate the safety and performance of the Virtue* Sirolimus Eluting Balloon for the treatment of in-stent restenosis (ISR) in native coronary arteries.
Approved WMOCompleted
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…