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Novel Endovascular Access Trial (NEAT) (NEAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TVA Medical Inc.
ClinicalTrials.gov Identifier:
NCT02036671
First received: January 10, 2014
Last updated: February 15, 2017
Last verified: October 2016
  Purpose
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.

Condition Intervention
Chronic Kidney Disease Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by TVA Medical Inc.:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: [ Time Frame: within 3 months ]
    The percentage of patients with fistula maturation/usability defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR patient was dialyzed using 2 needles.


Secondary Outcome Measures:
  • Safety Endpoint [ Time Frame: within 3 months ]
    The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation

  • EndoAVF-related Re-intervention Rate [ Time Frame: 3, 6 and 12 months ]
    The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) will be calculated at 3, 6 and 12 months post index procedure.

  • Primary Patency [ Time Frame: 3, 6 and 12 months ]
    Time from successful endoAVF creation to the first intervention designed to address thrombosis or stenosis, assist in maturation or cannulation of endoAVF, or endoAVF abandonment.

  • Cumulative Patency [ Time Frame: 3, 6 and 12 months ]
    Time from creation to the abandonment of endoAVF (censor patients with renal transplant)

  • Functional Usability [ Time Frame: 4 weeks post procedure, up to 12 months ]
    2-needle cannulation of the endoAVF for prescribed dialysis in ≥ 2/3 of dialysis sessions over a 4 consecutive week period within 12 months of endoAVF creation.


Enrollment: 80
Study Start Date: January 2014
Study Completion Date: October 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EndoAVF
The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

Detailed Description:
This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
  • Adult (age >18 years old).
  • Established, non-reversible kidney failure requiring hemodialysis.
  • Written informed consent obtained.

Exclusion Criteria:

  • Functioning surgical access in the planned treatment arm.
  • Pregnant women.
  • New York Heart Association (NYHA) class III or IV heart failure.
  • Allergy to contrast dye.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036671

Locations
Australia, Queensland
Princess Alexandra Hospital
Woolongabba, Queensland, Australia, 4102
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3181
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
QE II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
The Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
CHUM, Notre-Dame Hospital
Montreal, Quebec, Canada, H2L 4M1
New Zealand
Auckland City Hospital
Grafton, New Zealand, 1142
Sponsors and Collaborators
TVA Medical Inc.
Investigators
Principal Investigator: Charmaine Lok, MD, MSC, FRCPC The Toronto General Hospital
Principal Investigator: Dheeraj Rajan, MD, BSc, FRCPC, FSIR The Toronto General Hospital
  More Information

Responsible Party: TVA Medical Inc.
ClinicalTrials.gov Identifier: NCT02036671     History of Changes
Other Study ID Numbers: VAP-0001
Study First Received: January 10, 2014
Last Updated: February 15, 2017

Keywords provided by TVA Medical Inc.:
Arteriovenous fistula
Fistula
Chronic kidney disease
Percutaneous
Kidney Disease
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
CKD
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 28, 2017