Researchers at Advocate Aurora Research Institute’s Center of Excellence in Cardiovascular Research have joined the PEERLESS clinical trial comparing two types of medical devices currently available to treat pulmonary embolism, a potentially life-threatening condition caused by a blood vessel blockage in one of the lungs.
The blockage is produced by a blood clot that travels through the body’s chain of blood vessels, passes through the heart and enters an artery that supplies the lung. When the clot, or pulmonary embolism, lodges there and forms a blockage, it interrupts blood flow from the heart to the lung, which often results in strain on the heart muscle and reduced cardiovascular functioning.
“Elimination of the pulmonary embolism is the recommended treatment when we see specific evidence of cardiovascular dysfunction, referred to as acute intermediate-high-risk pulmonary embolism,” said cardiologist Joaquim Barboza, MD, the Research Institute’s lead investigator for the study at Advocate Christ Medical Center in Oak Lawn, Illinois. “Two treatment options have been approved for use in these cases. One is the FlowTriever System, a device designed to retrieve and remove the pulmonary embolism from the artery, and the other is catheter-directed thrombolysis, or CDT, which is a device that delivers an anti-clotting medicine to dissolve the clot.”
The objective of the PEERLESS clinical trial is to conduct a head-to-head comparison of the FlowTriever System and CDT devices in the treatment of acute intermediate-high-risk PE.
“There are known risks and benefits for each device used in treating pulmonary embolism,” said cardiologist Ramagopal Tumuluri, MD, the Research Institute’s lead investigator for the study at Aurora St. Luke’s Medical Center in Milwaukee. “During the trial, we will be collecting and analyzing data on health outcomes after each treatment with the goal of obtaining evidence that will help us optimize treatment decisions in the future.
Researchers plan to enroll approximately 550 research participants in the trial at clinical trial sites around the world, and the participants will be randomly assigned to either the FlowTriever System or CDT group. An additional group of up to 150 participants whose medical condition prohibits the use of anti-clotting medicines will be enrolled, treated with FlowTriever and analyzed separately.
“A comparison of medical devices that have been approved for treatment is an important next step to determine if one may be better than another in certain individuals or specific situations,” said Laura Wrona, MSN, director of the Center of Excellence in Cardiovascular Research at the Research Institute. “We’re honored to support post-market clinical trials, like PEERLESS, that ultimately will result in improved health outcomes for our patients.”
The PEERLESS study is sponsored by Inari Medical Inc., manufacturer of the FlowTriever® Retrieval/Aspiration System.
To learn more about Advocate Aurora’s research, visit aurora.org/research.