The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).
BIOFLOW-VII is a prospective, multicenter, single-arm study. Subjects with coronary artery disease (CAD) who undergo an on-label percutaneous coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened post-index procedure per the protocol inclusion and exclusion criteria. Following the index procedure and study enrollment, subjects will be followed for 5 years. The follow-up schedule will include an intermediate study visit at 1 month, a primary endpoint study visit at 12 months, and long-term study visits at 2, 3, 4, and 5 years.
Study Type
OBSERVATIONAL
Enrollment
556
Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
Cardiology Associates of Mobile
Fairhope, Alabama, United States
John Muir Medical Center
Concord, California, United States
St. Joseph Hospital Orange
Orange, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Tampa
Tampa, Florida, United States
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Time frame: 12-Months
All-cause Death
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Protocol-defined Any-vessel Myocardial Infarction
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Lesion Revascularization (TLR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Vessel Revascularization (TVR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Cardiac Death or Protocol-defined Any-vessel MI
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Stent Thrombosis
Time frame: at 24 Hours, at 1 Month, at 1 Year
Number of Lesions With Device Success
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only.
Time frame: at Hospital Discharge an average of 1 day
Number of Lesions With Lesion Success
Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method.
Time frame: at Hospital Discharge an average of 1 day
Number of Participants With Procedure Success
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Time frame: at Hospital Discharge an average of 1 day
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Piedmont Heart Institute
Atlanta, Georgia, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Ascension St. Vincent Medical Group
Indianapolis, Indiana, United States
...and 23 more locations