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

Cytograft Tissue Engineering

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hemodialysis

ESRD

Treatments

Device: Lifeline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00850252

R44HL064462-06 (U.S. NIH Grant/Contract)

Cytograft A-V

Details and patient eligibility

About

This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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