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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ESRD Hemodialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifeline blood vessel

Group Type EXPERIMENTAL

Lifeline

Intervention Type DEVICE

Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Interventions

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Lifeline

Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Intervention Type DEVICE

Other Intervention Names

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Tissue engineered blood vessel

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No