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Clinical Trials/NCT01929369
NCT01929369CompletedNot Applicable

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

Volcano Corporation1 site in 1 country100 target enrollmentStarted: August 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Define IVUS workflow

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Define IVUS workflow

Time Frame: Day 0

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

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

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

  • Assess CHROMOFLO in AV grafts(Day 0)
  • IVUS vs DSA alone- Decision making(Day 0)
  • % patients requiring re-intervention(3 months and 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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