Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961852
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-17
Brief Title:
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis CONCERTO
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis CONCERTO
Status:
COMPLETED
Status Verified Date:
2023-07
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:
CONCERTO
Brief Summary:
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis
Detailed Description:
This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis defined as having 30 residual stenosis after optimal balloon angioplasty to receive cutting and drug-coated balloon
The outcome measure is target lesion primary patency at 6 months Outcome will be clinically driven
The outcome measure is target lesion primary patency at 6 months Outcome will be clinically driven
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None