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

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.

Official Title
-----------------
Use of a Completely Autologous and Completely Biological Tissue Engineered Blood Vessel Lifeline as an Arteriovenous Fistula in Hemodialysis Patients - Safety and Efficacy Study.

Conditions
-----------------
ESRD, Hemodialysis

Intervention / Treatment
-----------------
* Device: Lifeline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifeline blood vessel<br> | Device: Lifeline<br>* Surgical arteriovenous fistula formation with the use of Lifeline blood vessel<br>* Other names: Tissue engineered blood vessel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula |  | minimum 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lifeline, Tissue engineered blood vessel, A-V shunt