Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

Ethicon

Status and phase: Completed; Phase 3

Conditions: Peripheral Vascular Disease

Treatments: Drug: Fibrin sealant (FS2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154141

400-05-001

Details and patient eligibility

About

A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
• Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
• Subjects must be willing to and capable of participating in the study, and provided written informed consent.

Exclusion criteria

• Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
• Subjects undergoing emergency surgery.
• Subjects with any intra-operative findings that may preclude conduct of the study procedure.
• Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
• Subjects unwilling to receive blood products.
• Subjects with autoimmune immunodeficiency diseases (including known HIV).
• Subjects who are known, current alcohol and / or drug abusers.
• Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
• Female subjects who are pregnant or nursing.