NCT00850252CompletedPhase 1
Use of a Completely Autologous and Completely Biological Tissue Engineered Blood Vessel Lifeline as an Arteriovenous Fistula in Hemodialysis Patients - Safety and Efficacy Study.
Cytograft Tissue Engineering2 sites in 2 countriesStarted: September 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Locations
- 2
- Primary Endpoint
- The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
Study Overview
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 access.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
Time Frame: minimum 3 months
Secondary Outcomes
- The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients(36 months)
Investigators
Study Sites (2)
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