Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

E

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.

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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