Trials / Completed
CompletedNCT04698512
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
MAgic Touch™ Intervention Leap for Dialysis Access (MATILDA) Trial
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Singapore General Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
For patients with End Stage Renal Failure (ESRF), the surgical creation of an Autogenous Arteriovenous Fistula (AVF) or Autogenous Arteriovenous Graft (AVG) is the recognised standard for providing vascular access. A functioning dialysis vascular access is essential to facilitate hemodialysis (HD) treatment. Advantages include improved hemodialysis initiation time, improved dialysis quality, better maintenance of accesses and generally, better outcomes in patients. Unfortunately almost 50% of AVF and AVG fail after a median lifetime of 3 to 7 years and 12 to 18 months respectively. Vascular access dysfunction is a major cause of morbidity and hospitalisation for ESRF patients, costing the healthcare system USD 18 million globally. Venous stenosis and scarring are caused by trauma from surgical access creation when the circuit comes arterialized and from repeated percutaneous punctures from subsequent hemodialysis. This study is performed to evaluate Sirolimus-coated balloon efficacy and safety using MagicTouch™ Drug coated balloon catheter (Concept Medical Inc, Tampa, FL, US) on AVF patency with de novo and recurrent stenosis.
Conditions
- Dialysis Access Malfunction
- End Stage Renal Failure on Dialysis
- End Stage Renal Disease
- Fistulas Arteriovenous
- Stenosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AVFistuloplasty with Sirolimus coated balloon | After an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon |
Timeline
- Start date
- 2019-05-21
- Primary completion
- 2020-01-16
- Completion
- 2021-01-30
- First posted
- 2021-01-07
- Last updated
- 2021-03-17
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT04698512. Inclusion in this directory is not an endorsement.