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Completed

NCT Number: NCT01929369

Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts

This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm) was derived in consultation with the study PI and Co-PI who are experts in vascular surgery, and in particular, the field of hemodialysis access interventions. The results of this pilot study will provide the data that is necessary for generation of specific hypotheses that can then be formally tested in the follow-up RCT

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Key information

Conditions

THROMBOSED AV GRAFTS Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Medical Center

Orangeburg, South Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must be > 18 and < 85 years of age
  • Patient or legally authorized representative must be willing to participate and able to understand, read, and sign the informed consent document before the planned procedure
  • Eligible for de-clot procedure or evaluation of slow flow for a failing hemodialysis graft that previously provided access for at least 1 successful hemodialysis session

Exclusion criteria

  • Patient or legally authorized representative cannot or will not provide written informed consent
  • Known metal allergy precluding endovascular stent implantation
  • Known reaction or sensitivity to iodinated contrast that cannot be pretreated
  • Patients who are pregnant or lactating
  • Patients with scheduled kidney transplant within the next 6 months
  • Patients scheduled to switch to peritoneal dialysis within the next 6 months
  • Patients with life expectancy of less than 6 months
  • Participation in any other clinical research study that would interfere with the patient's participation in this study
  • Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study

Treatment and study plan

Primary outcomes

  1. Re-Intervention Control vs. Test

    Time frame: 6 months

    Difference in time (measured in days) to AV graft failure after index intervention guided by DSA in the absence (control group) or presence of IVUS guidance (test group), assessed through 6 months post-index procedure

  2. Define IVUS workflow

    Time frame: Day 0

    Define IVUS workflow for AV graft evaluation during interventions for access site failure

  3. Evaluate ability of IVUS in AV Grafts

    Time frame: Day 0

    Evaluate the ability of IVUS to identify targets for therapy in poorly functioning AV grafts that are not identified by DSA

Secondary outcomes

  1. IVUS vs DSA alone- Decision making

    Time frame: Day 0

    Percentage of time IVUS changes decision making during the index procedure (test group)

  2. % patients requiring re-intervention

    Time frame: 3 months and 6 months

    Percentage of patients with graft failure or need for reintervention at 3 months and 6 months (c0ntrol and test)

  3. Assess CHROMOFLO in AV grafts

    Time frame: Day 0

    Assess the ability of ChromaFlo® to identify residual thrombus in the hemodialysis access circuit

Sponsors and collaborators

Lead sponsor

Volcano Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2013
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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