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

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 Overview

• Status: Completed
• Conditions: THROMBOSED AV GRAFTS

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Orangeburg, South Carolina, United States
      • Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ESRD PATIENTS WITH THROMBOSED AV GRAFTS

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Volcano Corporation
• Investigators: Principal Investigator: John Ross, MD, Regional Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: CKD; ESRD; AV GRAFTS; THROMBOSED AV GRAFTS
• Other Study ID Numbers: Ross Pilot