NCT00850252

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

7.3 years

First QC Date

February 20, 2009

Last Update Submit

July 15, 2013

Conditions

ESRDHemodialysis

Keywords

LifelineTissue engineered blood vesselA-V shunt

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Lifeline blood vessel

EXPERIMENTAL
Device: Lifeline

Interventions

LifelineDEVICE

Surgical arteriovenous fistula formation with the use of Lifeline blood vessel

Also known as: Tissue engineered blood vessel
Lifeline blood vessel

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

Location

Department of General, Vascular and Transplant Surgery

Katowice, Poland

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Vessel Prosthesis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 24, 2009

Study Start

September 1, 2004

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

PL(1)AR(1)