Trials / Completed
CompletedNCT05961852
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Singapore General Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Angioplasty | Angioplasty with cutting and drug-coated balloon |
Timeline
- Start date
- 2018-08-15
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
- First posted
- 2023-07-27
- Last updated
- 2023-07-27
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05961852. Inclusion in this directory is not an endorsement.