Use of a Lifeline Graft in the A-V Shunt Model

Inclusion criteria

• Have signed an informed consent
• Patients ≥ 21 years old
• Patients not candidates for a Brescia-Cimino A-V fistula (own vessels)
• Have an AV shunt or fistula that will likely fail within 12 months because of:

• Signs of clinical dysfunction: increment of venous pressure, limited site of puncture, stenosis, aneurysm dilatations that cannot be surgically repaired or by other media, or
• Previous angioplasty, or
• Previous thrombolysis
• Fall into category of ASA grade 2 or below (or UK equivalent)
• Are willing and able to comply with 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and 52 week follow up and able to comply with biannual follow up thereafter.

Exclusion criteria

• A need for urgent surgery
• Penicillin allergy
• Patients with uncontrolled hypertension
• Morbid obesity (> 300 lbs)
• Active systemic infection
• Contraindication for anticoagulation
• Coagulopathy
• Acute renal failure
• Connective tissue diseases (i.e. Marfan's syndrome)
• Pregnant or nursing
• Life expectancy < 1 year
• Participation in another study involving an investigational device or new drug
• Other medical, social or psychological issues that, in the opinion of the principal investigator, preclude them from receiving the treatment and the procedures/evaluations of the post-operative follow up
• Inability or unwillingness to comply with the scheduled follow-up visit