Research Study for High Risk Patients Requiring Balloon Dilation or Stenting

The University of Chicago and Dr. Neeraj Jolly are conducting a research study for high risk patients that have a significant narrowing or blockage in an artery (also called "hardening of the arteries") in the heart. To open up the blockage, patients may undergo balloon dilatation (expansion of the artery at the location of the narrowing) and/or a stent implantation. A stent is a hollow flexible, metal tube that keeps the dilated part of the vessel open. Since high risk patients' hearts are weak, the standard strategy is to temporarily support the heart using a device called an intra-aortic balloon pump (IABP). A newer device called the circulatory assist device is slated to provide stronger support to a weak heart during these procedures. This device may be used for short-term purposes, allowing the heart to "rest" long enough so that it can recuperate and return to normal, independent function.

This purpose of this research study is to determine whether the placement of a circulatory assist device early in the procedure is better to improve outcome and to compare an experimental circulatory assist device and the routinely-used IABP. The word "experimental" means the device system is still being tested and is not approved by the FDA (Food and Drug Administration). During this study you will be randomly assigned (like the flip of a coin) to one of two groups. One group will receive a routine device called a intra-aortic balloon pump (IABP) and the other group will receive the experimental device system.

You will be in this study for about 3 months. Some of the procedures that will be done during this study are: physical exams, echocardiograms, electrocardiograms (EKGs), blood and urine testing, a surgical procedure to insert the experimental device. After the initial procedures, you will see a study doctor 30 days and 3 months after the completion of the heart procedure.

Benefits

You may not receive any direct medical benefit from participating in this study. Your participation may provide information about that may benefit other patients needing a circulatory assist device in the future.

Participation Details

• Must be at least 18 years of age
• Must not be pregnant
• Must meet study medical criteria as evaluated by Dr. Jolly

Study Director: Dr. Neeraj Jolly
Department: Cardiology

For more information contact:
Emily Bayer
ebayer@medicine.bsd.uchicago.edu
(773) 702-0347

IRB: #15899A