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

Phase 1

Completed

• Conditions: ESRD; Hemodialysis
• Interventions: Device: Lifeline

• Registration Number: NCT00850252
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-24
• Primary Completion: 2012-01
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifeline blood vessel	Lifeline	-

Primary Outcome Measures

Name	Time	Method
The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula	minimum 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Instituto Argentino de Diagnostico y Tratamiento; 🇦🇷 Buenos Aires, Argentina

Department of General, Vascular and Transplant Surgery; 🇵🇱 Katowice, Poland