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Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae (SAVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vital Access Corp.
ClinicalTrials.gov Identifier:
NCT01471041
First received: November 1, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.


Condition Intervention Phase
End Stage Renal Disease
AV Fistula
Kidney Failure
Device: Venous Window Needle Guide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

Resource links provided by NLM:


Further study details as provided by Vital Access Corp.:

Primary Outcome Measures:
  • Use of Venous Window Needle Guide to obtain arteriovenous access for hemodialysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.


Secondary Outcome Measures:
  • Arteriovenous fistula cannulation complications while using the Venous Window Needle Guide [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide


Enrollment: 54
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venous Window Needle Guide
Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Device: Venous Window Needle Guide
Subcutaneous, extravascular needle guide made of medical-grade titanium
Other Name: VWNG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Deep, uncannulatable, upper extremity arteriovenous fistula
  • Minimum arteriovenous fistula flow 400 ml/min
  • One year life expectancy

Exclusion Criteria:

  • Non-transposed basilic or brachial vein arteriovenous fistula
  • History of peripheral vascular disease
  • History of cardiovascular disease
  • History of cerebral vascular disease
  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: NCT01471041

Locations
United States, California
Ladenheim Dialysis Access Centers
Fresno, California, United States, 93710
United States, Oklahoma
University of Oklahoma - Tulsa
Tulsa, Oklahoma, United States, 74104
Sponsors and Collaborators
Vital Access Corp.
Investigators
Study Director: Mark Crawford, BA Vital Access
  More Information

No publications provided by Vital Access Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vital Access Corp.
ClinicalTrials.gov Identifier: NCT01471041     History of Changes
Other Study ID Numbers: VA 024
Study First Received: November 1, 2011
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vital Access Corp.:
End Stage Renal Disease
Hemodialysis
AV fistula
Kidney failure

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases
Vascular Fistula
Vascular Malformations

ClinicalTrials.gov processed this record on November 27, 2014