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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00850252
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : July 17, 2013
Information provided by (Responsible Party):
Cytograft Tissue Engineering

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.

Condition or disease Intervention/treatment Phase
ESRD Hemodialysis Device: Lifeline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : September 2004
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
Experimental: Lifeline blood vessel Device: Lifeline
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
Other Name: Tissue engineered blood vessel

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00850252

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Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, Argentina
Department of General, Vascular and Transplant Surgery
Katowice, Poland
Sponsors and Collaborators
Cytograft Tissue Engineering
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Principal Investigator: Luis M de la Fuente, MD IADT, Buenos Aires, Argentina
Principal Investigator: Lech Cierpka, MD PhD Department of General, Vascular and Transplant Surgery, Katowice, Poland

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Responsible Party: Cytograft Tissue Engineering Identifier: NCT00850252     History of Changes
Other Study ID Numbers: Cytograft A-V
R44HL064462-06 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013
Keywords provided by Cytograft Tissue Engineering:
Tissue engineered blood vessel
A-V shunt