Postinterventional percutaneous closure of femoral artery access sites using the Clo-Sur PAD device: initial findings.

The purpose of this study was to evaluate a percutaneous hemostatic device in patients to achieve immediate hemostasis at the vascular access site as well as early ambulation after vascular interventional procedures. In a randomized trial, a hemostatic device (Clo-Sur PAD, Medtronic AVE, Inc., Santa Rosa, CA, USA; n=60) was compared with manual compression (n=60) in patients after endoluminal intervention through an inguinal access (sheath sizes: 5-7 French). Device safety was evaluated by assessing complications within 24 h and 14 days. System efficacy was measured by the percentage of achieved immediate hemostasis and early ambulation. Device application was possible in 57 cases (95.0%), with 93.3% (56/60) of the patients rising 2 h after application. Hemostasis time was 10.15+/-1.96 min (control group: 16.20+/-1.79 min), with a pressure bandage time of 3.47+/-5.53 h (control group: 13.8+/-4.32 h). Ambulation was possible after 2.13+/-0.50 h (control group: 8.57+/-3.47 h). Complications encountered were access-site bleeding with hematoma (device: n=3; control: n=9). All complications were managed conventionally without blood transfusion or surgical intervention. The system is an easy to use device permitting early ambulation without additional pressure bandaging in the majority of patients. Preliminary data show that hemostasis does not depend on the level of anticoagulation.

RCT Entities:   Population Interventions Outcomes