Clinical Information
Clinical trials have shown significant reductions in time to hemostasis and time to ambulation for the patients.
Proven Clinical Results
The Femoral Introducer Sheath and Hemostasis Device is superior to manual compression in both time to hemostasis, time to ambulation, and time to eligible discharge. Based on results from in vitro animal studies and human clinical studies, as well as the ongoing FISH clinical trial, there is valid scientific evidence that the FISH device is safe and effective.
Clinical Protocol
The FISH closure device was studied in a randomized controlled multi-center clinical trial which, thus far, has enrolled 292 patients. The study was conducted at The Cleveland Clinic (Cleveland, OH), St. Thomas Hospital (Nashville, TN), St. Vincent’s Indianapolis Hospital (Indianapolis, IN), Methodist Hospital (Indianapolis, IN), University of Kentucky Hospital (Lexington, KY), Bloomington Hospital (Bloomington, IN), and Penn State Hershey Medical Center (Hershey, PA). This U.S-based trial compared the FISH device to manual compression. Manual compression is the standard against which all vascular closure devices are compared. The study included patients undergoing diagnostic or therapeutic coronary or peripheral procedures performed via the common femoral artery. The procedures were done with an 8 French or smaller sheath size. There were a total of 40 investigators who enrolled patients for the study. Each investigator had the opportunity to enroll up to two roll-in patients, which were non-randomized patients. There were a total of 26 roll-in patients in the study for 40 investigators. This study included six U.S. sites and enrolled patients between January 2004 and June 2006. The patients agreed to return for a follow-up evaluation at 30 days.
Efficacy and Safety Results
The FISH device demonstrated significantly better time to hemostasis (TTH), time to ambulation (TTA), and time to discharge (TTD) compared to manual compression (MC) in both the diagnostic and therapeutic groups. For the diagnostic group, median TTH was 6 minutes for FISH versus 17 minutes for MC (p<0.0001). Median TTA was 2.0 hours for FISH versus 4.2 hours for MC (p<0.0001). TTD was 3.0 hours for FISH versus 4.9 hours for MC (p<0.0001). In addition, there was no significant difference in patient discomfort at 30 days post-procedure for the diagnostic group. For the interventional group, FISH performed significantly better than MC in all measures, except TTD. TTD did not differ in the interventional group since the cardiologists in the study preferred to keep most patients in the hospital for overnight observation regardless of the method of access site closure.
