PURPOSE: To evaluate the safety and efficacy of the QuickSeal system, which delivers an over-the-wire extravascular porcine gelatin sponge (nonbovine and noncollagen), compared with manual compression in a single interventional radiology practice. MATERIALS AND METHODS: This single-institution report involves 141 patients undergoing peripheral diagnostic and interventional procedures in a teaching and private-practice setting. A 3:2 device-to-control ratio was used with randomization stratified by type of procedure, interventional or diagnostic. Primary endpoints included time to hemostasis (TTH), time to ambulation (TTA), and rate of major complications. Sheaths were removed in the device group when activated clotting times (ACTs) were < or =300 seconds for patients without glycoprotein (GP) IIb/IIIa platelet inhibitors and < or =250 seconds for patients with GP IIb/IIIa platelet inhibitors. Sheaths were removed in the control group when ACTs were < or =180 seconds. RESULTS: The mean TTH was significantly shorter (P <.001) in the device group (8.2 minutes) than in the control group (14.12 minutes). Mean TTA was shorter in the device group (2.7 hours) than in the control group (7.1 hours), and the time to discharge was shorter in the device group (23.8 hours) than in the control group (43.6 hours). There were no major complications in either group, and the incidences of minor complications were not significantly different. CONCLUSION: The tested device reduced TTH, TTA, and eligibility for hospital discharge while maintaining a safety profile equivalent to that of manual compression in diagnostic and interventional procedures.
RCT Entities:
PURPOSE: To evaluate the safety and efficacy of the QuickSeal system, which delivers an over-the-wire extravascular porcine gelatin sponge (nonbovine and noncollagen), compared with manual compression in a single interventional radiology practice. MATERIALS AND METHODS: This single-institution report involves 141 patients undergoing peripheral diagnostic and interventional procedures in a teaching and private-practice setting. A 3:2 device-to-control ratio was used with randomization stratified by type of procedure, interventional or diagnostic. Primary endpoints included time to hemostasis (TTH), time to ambulation (TTA), and rate of major complications. Sheaths were removed in the device group when activated clotting times (ACTs) were < or =300 seconds for patients without glycoprotein (GP) IIb/IIIa platelet inhibitors and < or =250 seconds for patients with GP IIb/IIIa platelet inhibitors. Sheaths were removed in the control group when ACTs were < or =180 seconds. RESULTS: The mean TTH was significantly shorter (P <.001) in the device group (8.2 minutes) than in the control group (14.12 minutes). Mean TTA was shorter in the device group (2.7 hours) than in the control group (7.1 hours), and the time to discharge was shorter in the device group (23.8 hours) than in the control group (43.6 hours). There were no major complications in either group, and the incidences of minor complications were not significantly different. CONCLUSION: The tested device reduced TTH, TTA, and eligibility for hospital discharge while maintaining a safety profile equivalent to that of manual compression in diagnostic and interventional procedures.