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Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures

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ClinicalTrials.gov Identifier: NCT02056704
Recruitment Status : Unknown
Verified June 2015 by Baylor Research Institute.
Recruitment status was:  Recruiting
First Posted : February 6, 2014
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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Brief Summary:
The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.

Condition or disease Intervention/treatment Phase
Dialysis Access Malfunction Device: Angiography with IVUS Phase 4

Detailed Description:

Patients with kidney failure have a fistula or graft for long-term dialysis in order for the dialysis machine to draw blood, filter it, and give it back to the patient. Over time, the fistula or graft may not work well enough to use for dialysis, most commonly because the veins may develop "scar tissue" within and around them that narrows the vein resulting in poor flow or complete blockage.

These blockages are commonly opened with wires, balloons (a procedure called angioplasty), and stents. These blockages are seen with angiography, a special type of x-ray used with a dye that shows the inside of the blood vessels. Intravascular ultrasound (IVUS) is a type of imaging that uses sound waves to produce an image of the inside of blood vessels and to see their condition. Currently, it is not known if angiography alone or angiography with IVUS has better results. The reason we are doing this study is to compare the results of angiography versus angiography with IVUS.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
Study Start Date : May 2012
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Angiography
Evaluation by angiography only.
Experimental: Angiography with IVUS
Evaluation with angiography and intravascular ultrasound.
 Device: Angiography with IVUS
The use of IVUS to evaluate dialysis access failure.
Other Name: Volcano IVUS catheter


Outcome Measures
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Primary Outcome Measures :
  1. Change in characteristics of lesion within the vessel [ Time Frame: every 3 months - up to 2 years ]
    This will include vessel diameters proximal and distal to lesions, percent stenosis, and lesion lengths.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • > 18 years old
  • Male or female (non-pregnant females)
  • Patients with hemodialysis access failure (arteriovenous fistulae or arteriovenous grafts)
  • Patients must undergo elective angiographies (fistulograms) based on surveillance duplex ultrasound findings (stenosis)
  • Patients with outflow stenoses between 1 cm distal to an arterial anastamosis and clavicle in AV fistulae or between venous anastamosis and clavicle in AV grafts found on surveillance duplex ultrasound

Exclusion Criteria:

  • Patients with other etiologies (inflow lesions, intragraft lesions, hypercoagulable states, lesions not readily amenable to stenting), advanced failures (thrombosis, central venous occlusion), and non-routine access conformations (chest wall/groin grafts, balloon assisted maturation)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056704


Contacts
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Contact: Tammy Fisher, RN, MBA 214-820-7221 tammyfi@baylorhealth.edu
Contact: Martha Mueller, RN, BSN 214-820-7755 martha.mueller@baylorhealth.edu

Locations
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United States, Texas
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: William Shutze, MD         
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: William Shutze, MD         
Baylor Regional Medical Center at Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: William Shutze, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: William Shutze, MD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: William Shutze, MD Baylor Health Care System
More Information
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02056704    
Other Study ID Numbers: 012-088
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Keywords provided by Baylor Research Institute:
Dialysis Fistula
Dialysis Graft
Stenosis
Intravascular Ultrasound
Angiography