Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553443
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RANGER
Brief Summary:
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula AVF stenosis with that after conventional balloon angioplasty
Detailed Description:
This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 11 ratio to either drug-coated balloon Ranger or conventional balloon All peripheral AVF stenoses will be treated with the allocated balloon type
The primary outcome measure is 6-month access circuit patency
The primary outcome measure is 6-month access circuit patency
Study Oversight
Has Oversight DMC:
None
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?:
None