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

Hemodialysis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850252
• Other study ID #: Cytograft A-V
• Secondary ID: R44HL064462-06
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 20, 2009
• Last updated: July 15, 2013
• Start date: September 2004
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Cytograft Tissue Engineering
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ESRD
• Hemodialysis

Intervention

Device:
• Lifeline
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Locations

Country	Name	City	State
Argentina	Instituto Argentino de Diagnostico y Tratamiento	Buenos Aires
Poland	Department of General, Vascular and Transplant Surgery	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Cytograft Tissue Engineering

Countries where clinical trial is conducted

Argentina,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula		minimum 3 months	Yes
Secondary	The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients		36 months	Yes