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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytograft Tissue Engineering
ClinicalTrials.gov Identifier:
NCT00850252
First received: February 20, 2009
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
ESRD
Hemodialysis
Device: Lifeline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Cytograft Tissue Engineering:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Study Start Date: September 2004
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifeline blood vessel Device: Lifeline
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
Other Name: Tissue engineered blood vessel

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850252

Locations
Argentina
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, Argentina
Poland
Department of General, Vascular and Transplant Surgery
Katowice, Poland
Sponsors and Collaborators
Cytograft Tissue Engineering
Investigators
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
  More Information

No publications provided

Responsible Party: Cytograft Tissue Engineering
ClinicalTrials.gov Identifier: NCT00850252     History of Changes
Other Study ID Numbers: Cytograft A-V, R44 HL064462-06
Study First Received: February 20, 2009
Last Updated: July 15, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Cytograft Tissue Engineering:
Lifeline
Tissue engineered blood vessel
A-V shunt

Additional relevant MeSH terms:
Arteriovenous Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014