Trials / Completed
CompletedNCT05018962
Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Singapore General Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10). We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cutting balloon followed by paclitaxel coated balloon | Cutting balloon followed by paclitaxel coated balloon |
Timeline
- Start date
- 2017-09-08
- Primary completion
- 2019-04-15
- Completion
- 2020-03-18
- First posted
- 2021-08-24
- Last updated
- 2021-08-24
Locations
1 site across 1 country: Singapore
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05018962. Inclusion in this directory is not an endorsement.