Purpose of this Study
This study plans to enroll people over about 16 months. After a person receives treatment, doctors will follow them for 90 days to check their health and how well the treatment worked. The total study is expected to last about 19 months from start to finish.
Who Can Participate?
Eligibility
This study is for people who need a high risk heart procedure to open blocked heart arteries. They must have a weaker heart that does not pump strongly, with less than half of normal strength. They must also have serious blockages in important heart arteries, such as one main artery, three major arteries, or the last open artery that supplies blood to the heart. The study includes people whose doctors plan to use extra support during the procedure to help the heart keep working safely.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to learn if a device called the Supira System is safe and works well during certain high risk heart procedures. This device helps support the heart and blood flow for a short time while doctors open blocked heart arteries. It is used during planned or urgent procedures in people with serious heart disease who are stable at the time of treatment.
Locations
Other
Visit Timing
Weekdays
Evenings
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)-The SUPPORT II Trial
Principal Investigator
Daniel
Loriaux
Protocol Number
PRO00119421
NCT ID
NCT07296744
Phase
II
Enrollment Status
Pending Open to Enrollment