Trials / Completed
CompletedNCT01929369
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Volcano Corporation · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-09-01
- Completion
- 2014-12-01
- First posted
- 2013-08-27
- Last updated
- 2015-02-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01929369. Inclusion in this directory is not an endorsement.