Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT01929369
Status:
COMPLETED
Last Update Posted:
2015-02-20
First Post:
2013-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
Sponsor:
Volcano Corporation
Organization:
Study Overview
Official Title:
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: