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 Type
OBSERVATIONAL
Enrollment
100
Regional Medical Center
Orangeburg, South Carolina, United States
Re-Intervention Control vs. Test
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
Time frame: 6 months
Define IVUS workflow
Define IVUS workflow for AV graft evaluation during interventions for access site failure
Time frame: Day 0
Evaluate ability of IVUS in AV Grafts
Evaluate the ability of IVUS to identify targets for therapy in poorly functioning AV grafts that are not identified by DSA
Time frame: Day 0
IVUS vs DSA alone- Decision making
Percentage of time IVUS changes decision making during the index procedure (test group)
Time frame: Day 0
% patients requiring re-intervention
Percentage of patients with graft failure or need for reintervention at 3 months and 6 months (c0ntrol and test)
Time frame: 3 months and 6 months
Assess CHROMOFLO in AV grafts
Assess the ability of ChromaFlo® to identify residual thrombus in the hemodialysis access circuit
Time frame: Day 0
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