Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
Completed
Conditions studied: THROMBOSED AV GRAFTS
In brief
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
Key facts
- Study ID
- NCT01929369
- Run by
- Volcano Corporation
- People needed
- 100
- Starts
- 2013-08-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-02-20
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Regional Medical Center — Orangeburg, South Carolina, United States
Full record on ClinicalTrials.gov
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