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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00850252

Enrollment

Unknown

Registered

2009-02-24

Start date

2004-09-30

Completion date

2012-12-31

Last updated

2013-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD, Hemodialysis

Keywords

Lifeline, Tissue engineered blood vessel, A-V shunt

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.

Interventions

DEVICELifeline

Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Argentina, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026