Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT01500135
Eligibility Criteria:
Main Inclusion Criteria:
* Planned elective and subacute 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, aorto-(bi)femoral, axillo-(bi)femoral, femoro-popliteal, femoro-crural bypass grafting), a PTFE patch angioplasty of the femoral artery, or an end-to-side anastomosis of a PTFE graft to an upper extremity artery in connection with arteriovenous bypass grafting for dialysis access.
* The evaluation site for the planned femoral anastomosis must be a de novo site.
* The participant must be heparinized during surgery.
Intra-operatively (before randomization)
* The participant 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).
* Liver cirrhosis.
Intra-operatively (before randomization)
* Severe bleeding at the anastomosis of the arterial bypass using PTFE graft prosthesis or the PTFE patch angioplasty
* No bleeding (dry surgical field) at the targeted application area
* Disseminated intravascular coagulopathy (DIC)
* Application of topical hemostatic material including fibrin sealant/glue on the evaluation site.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01500135
Study Brief:
Protocol Section:
NCT01500135