Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment in Vascular Surgery

Main Inclusion Criteria:

- Planned elective and sub acute procedures with a polytetrafluoroethylene (PTFE) graft
including at least one expected end-to-side anastomosis of a PTFE graft to the
femoral artery (e.g. femoral-femoral cross-over, femoro-popliteal, femoro-crural
bypass grafting) or a PTFE patch angioplasty of the femoral artery

- The evaluation site for the planned femoral anastomosis must be a de novo site

Intra-operatively (before randomization)

- The subject has a need for secondary hemostatic treatment

- Verification of the evaluation site being a de novo site

- Verification of the surgical procedure performed as being either an end-to-side or
PTFE patch angioplasty

Main Exclusion Criteria:

- Thrombolytic therapy administered within 12 hours before surgery (e.g. the
recombinant tissue plasminogen activator (rt-PA) Alteplase)

Intra-operatively (before randomization)

- Severe bleeding at the anastomosis of the arterial bypass using PTFE graft prosthesis
or the PTFE patch angioplasty

- Disseminated intravascular coagulopathy (DIC)

- Application of topical hemostatic material including fibrin sealant/glue on the
evaluation site