Clinical trial NCT00850252: Use of a Lifeline Graft in the A-V Shunt Model
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ESRD
Hemodialysis
Keywords: Lifeline
Tissue engineered blood vessel
A-V shunt
Lead sponsor: Cytograft Tissue Engineering
Sponsor class: INDUSTRY
First posted: 2009-02-24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
timeFrame: minimum 3 months
Secondary outcomes:
measure: The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients
timeFrame: 36 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnostico y Tratamiento
city: Katowice
country: Poland
facility: Department of General, Vascular and Transplant Surgery
Study officials:
affiliation: IADT, Buenos Aires, Argentina
name: Luis M de la Fuente, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General, Vascular and Transplant Surgery, Katowice, Poland
name: Lech Cierpka, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: