Clinical trial NCT01929369: Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
Official title: Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: THROMBOSED AV GRAFTS
Keywords: ESRD
CKD
AV GRAFTS
THROMBOSED AV GRAFTS
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD PATIENTS WITH THROMBOSED AV GRAFTS

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


Eligibility criteria: 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

Primary outcomes:
measure: Re-Intervention Control vs. Test
timeFrame: 6 months
measure: Define IVUS workflow
timeFrame: Day 0
measure: Evaluate ability of IVUS in AV Grafts
timeFrame: Day 0
Secondary outcomes:
measure: IVUS vs DSA alone- Decision making
timeFrame: Day 0
measure: % patients requiring re-intervention
timeFrame: 3 months and 6 months
measure: Assess CHROMOFLO in AV grafts
timeFrame: Day 0
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: Regional Medical Center
state: South Carolina
Study officials:
affiliation: Regional Medical Center
name: John Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: