UW Medicine conducting national clinical trial on inflatable tubular stent

Editor's Note

Cardiologists at the University of Washington School of Medicine (UW Medicine) in Seattle, Washington, are participating in a national clinical trial to test a device designed to control bleeding if a vessel near the heart is inadvertently perforated during a catheter-based procedure, Healthcare Purchasing News May 26 reported.

According to the UW Medicine news release, this clinical trial is testing a new device—an inflatable, ring-shaped stent designed to control bleeding while also permitting blood to flow normally through the vessel. This test device would “apply pressure to the bleeding and supply blood flow at the same time” to give the physician “a chance to stop and reevaluate the situation,” said Dr Kathleen Kearney, interventional cardiologist at the UW Medicine Heart Institute and an investigator in this clinical trial.

In other words, this device could be a solution to perforated vessels, which cause bleeding that must be controlled immediately to save the patient’s life and are often a complication of heart procedures that are now performed by cardiologists using catheters and guidewires instead of by surgeons in the OR.

Up to 15 US hospitals will participate in the study and up to 30 patients will be enrolled. “Importantly, since patients in this life-threatening circumstance would be under sedation and unable to give informed consent to be involved, the researchers leading the trial have acquired a federal exception that allows them to enroll patients without consent,” the news release noted.

Patients enrolled in the study will be notified after the procedure when they are awake and alert. A patient whose vessel is perforated and whose alternative, in that moment, is surgery would be a candidate for trial enrollment, Kearney said, adding that the ring balloon would be advanced into place using the guidewire already in the vessel.