Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03189667
Status:
TERMINATED
Last Update Posted:
2019-05-01
First Post:
2017-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Sponsor:
King Abdullah International Medical Research Center
Organization:
Study Overview
Official Title:
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
Detailed Description:
Objectives of the Study:
Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons
Aim of the Study:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.
Specific Objectives:
Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.
Primary safety endpoint: Peri procedural complication rate
Secondary endpoints:
* Technical success (\<30% residual stenosis without postdilation)
* Access circuit dysfunction free survival (Time to event) based on functional criteria
* Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)
Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons
Aim of the Study:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.
Specific Objectives:
Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.
Primary safety endpoint: Peri procedural complication rate
Secondary endpoints:
* Technical success (\<30% residual stenosis without postdilation)
* Access circuit dysfunction free survival (Time to event) based on functional criteria
* Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: