Status:
COMPLETED
Use of a Lifeline Graft in the A-V Shunt Model
Lead Sponsor:
Cytograft Tissue Engineering
Conditions:
ESRD
Hemodialysis
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00850252
Start Date
September 1 2004
End Date
December 1 2012
Last Update
July 17 2013
Active Locations (2)
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1
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, Argentina
2
Department of General, Vascular and Transplant Surgery
Katowice, Poland