Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 5/3/2014 |
| Start Date: | August 2013 |
| Contact: | Bradley Matsubara, MD |
| Email: | bmatsubara@volcanocorp.com |
| Phone: | 858-720-4045 |
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
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
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
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