Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

NARecruitingINTERVENTIONAL
Enrollment

860

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

May 1, 2025

Study Completion Date

September 1, 2025

Conditions
Diabetes MellitusCoronary Artery DiseaseAcute Coronary Syndrome
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (1)

14080

RECRUITING

Instituto Nacional de Cardiología Ignacio Chávez, Mexico City

All Listed Sponsors
lead

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER