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

Study Overview
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Brief Summary
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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

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

Conditions
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THROMBOSED AV GRAFTS

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CONTROL GROUP<br>Control group: index intervention guided by DSA; IVUS post-intervention only (50 patients) | |
| TEST GROUP<br>Test group: index intervention guided by IVUS + DSA (50 patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Define IVUS workflow | Define IVUS workflow for AV graft evaluation during interventions for access site failure | 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 | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVUS vs DSA alone- Decision making | Percentage of time IVUS changes decision making during the index procedure (test group) | 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) | 3 months and 6 months | 
| Assess CHROMOFLO in AV grafts | Assess the ability of ChromaFlo® to identify residual thrombus in the hemodialysis access circuit | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, CKD, AV GRAFTS, THROMBOSED AV GRAFTS