A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA.

Background: The prolonged bed rest following femoral sheath removal after PTCA is a source of discomfort for the patient. We designed a randomized study to evaluate the efficacy and safety of an arterial suture device developed to percutaneously close the vascular access site after PTCA, allowing immediate sheath removal and early ambulation, compared to manual compression.

Methods: After successful PTCA, patients were randomized to manual compression or immediate femoral percutaneous closure.