40
Participants
Start Date
January 31, 2027
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2028
Prolonged inflation
Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with \<0.3 atm drop during that period.
Rapid inflation
The rapid inflation method will consist of reaching an operator determined high-pressure (16 atm) with the stent-deployment balloon and maintaining it the duration of time determined by the operator but \<30 sec if the balloon is fully inflated and longer only if the balloon requires a longer duration to become fully inflated.
John L. McClellan Memorial Veterans Hospital, Little Rock
Central Arkansas Veterans Healthcare System
FED