Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03189667
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)
Study:
NCT03189667
Study Brief:
Protocol Section:
NCT03189667