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NCT01929369 · ClinicalTrials.gov registry record
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
A clinical trial, sponsored by Volcano Corporation.
- Completed
- Registry status
- 100
- Enrollment target
NCT01929369: Completed study, sponsored by Volcano Corporation.
NCT01929369 is a clinical trial that has completed, run by Volcano Corporation. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01929369 has completed, sponsored by Volcano Corporation.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study 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
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-12 |
What the finished NCT01929369 record still lists
NCT01929369 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01929369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01929369 about?
NCT01929369 is a clinical study titled "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 w...
What is the current status of trial NCT01929369?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2013-08. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01929369?
This trial is sponsored by Volcano Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
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