Trials / Completed
CompletedNCT04327609
SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- M.A. Med Alliance S.A. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SELUTION SLR™ DEB | Subjects will receive standard high-pressure balloon angioplasty followed by local application of sirolimus with the SELUTION SLR™ 018 DEB (MedAlliance) of appropriate diameter and length to achieve full lesion coverage. |
| DEVICE | Control Arm | The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment. |
Timeline
- Start date
- 2020-04-10
- Primary completion
- 2024-02-01
- Completion
- 2025-07-23
- First posted
- 2020-03-31
- Last updated
- 2025-08-29
Locations
3 sites across 2 countries: Greece, Singapore
Source: ClinicalTrials.gov record NCT04327609. Inclusion in this directory is not an endorsement.