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

CompletadoFase 2ClinicalTrials.gov

ID: NCT00850252Tipo: INTERVENTIONALInicio: 1 de sept de 2004Fin estimado: 1 de dic de 2012

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 21 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

device

Lifeline

Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Ubicaciones

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

Patrocinadores

PrincipalCytograft Tissue Engineering

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