To evaluate safety and efficacy results of the first clinical QuikClot Interventional Hemostatic Bandage use for femoral artery closure after diagnostic or interventional procedures.
The first European safety study was performed at the Centro Cardiologico Monzino in Milan, Italy, on January 2010. Forty consecutive patients (75%male, mean age 68 卤 11 years) undergoing diagnostic angiography (62%) or PCI (38%) by femoral approach with a 6- (90%) or 7-Fr (10%) size introducer, received arterial sheath removal with the QuikClot Interventional gauze use. The mean ACT value at hemostasis time was 138 卤 24 s (range 95-186 s). Hemostasis was achieved in a mean time of 4.9 卤 0.5 min. Only one hemostasis failure occurred requiring prolonged mechanical compression. Neither major bleeding, re-bleeding nor hematoma occurred after early (4 h after procedure) ambulation.
QuikClot Interventional Bandage obtained prompt hemostasis and allowed for an early ambulation without clinical complications.