Use of a Lifeline Graft in the A-V Shunt Model | NCT00850252

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

NCT00850252

Sponsor

Cytograft Tissue Engineering

Status

Completed

Last Update Posted

Jul 17, 2013Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

ESRD
Hemodialysis

Interventions

Lifeline

Countries

Argentina
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R44HL064462-06	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Jan 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 20, 2009

First Submission Date that Met QC Criteria

Feb 20, 2009

First Posted Date

Feb 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2013

Last Update Posted Date

Jul 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Lifeline blood vessel	Experimental		Device: Lifeline

Name	Type	Description	Arm Group Labels	Other Names
Lifeline	Device	Surgical arteriovenous fistula formation with the use of Lifeline blood vessel	Lifeline blood vessel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Argentino de Diagnostico y Tratamiento		Buenos Aires			Argentina
Department of General, Vascular and Transplant Surgery

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies