Hemostasis,Surgical Clinical Trial
Official title:
The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and
efficacy of the QuickClose device using two different dose types of heat exposure.
Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose
device. Two groups of 20 patients each, will be enrolled consecutively, Group A will
complete enrollment before enrollment into Group B begins. Patients will be monitored until
30 days after the procedure
The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care