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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL GROUP | Control group: index intervention guided by DSA; IVUS post-intervention only (50 patients) | ||
| TEST GROUP | Test group: index intervention guided by IVUS + DSA (50 patients |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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ESRD PATIENTS WITH THROMBOSED AV GRAFTS
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| Name | Affiliation | Role |
|---|---|---|
| John Ross, MD | Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Medical Center | Orangeburg | South Carolina | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |