860
Participants
Start Date
October 1, 2020
Primary Completion Date
May 1, 2025
Study Completion Date
September 1, 2025
Abluminus Sirolimus Eluting Stent System (ASES)
"The procedure will be conducted in accordance with the CE mark instructions for use for the ASES.~The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion."
Orsiro Sirolimus Eluting Coronary Stent System (OSES)
"The procedure will be conducted in accordance with the CE mark instructions for use for the OSES.~The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion."
RECRUITING
Instituto Nacional de Cardiología Ignacio Chávez, Mexico City
Instituto Nacional de Cardiologia Ignacio Chavez
OTHER