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

Completed

• Conditions: THROMBOSED AV GRAFTS

• Registration Number: NCT01929369
• Lead Sponsor: Volcano Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patient must be > 18 and < 85 years of age
2. 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
3. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Define IVUS workflow	Day 0	Define IVUS workflow for AV graft evaluation during interventions for access site failure
Re-Intervention Control vs. Test	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	Day 0	Evaluate the ability of IVUS to identify targets for therapy in poorly functioning AV grafts that are not identified by DSA

Secondary Outcome Measures

Name	Time	Method
Assess CHROMOFLO in AV grafts	Day 0	Assess the ability of ChromaFlo® to identify residual thrombus in the hemodialysis access circuit
IVUS vs DSA alone- Decision making	Day 0	Percentage of time IVUS changes decision making during the index procedure (test group)
% patients requiring re-intervention	3 months and 6 months	Percentage of patients with graft failure or need for reintervention at 3 months and 6 months (c0ntrol and test)

Trial Locations

Locations (1)

Regional Medical Center; 🇺🇸 Orangeburg, South Carolina, United States