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

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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Key information

Conditions

ESRD Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto Argentino de Diagnostico y Tratamiento, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifeline

Device

Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Other names: Tissue engineered blood vessel

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

Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Cytograft Tissue Engineering

Industry

Registry information

Official study 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.

Important dates

Study start: 2004
Primary completion: 2012
Study completion: 2012
First posted: Feb 24, 2009
Registry last updated: Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed