Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06056206 |
Other study ID # |
1037/2023 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 20, 2023 |
Est. completion date |
October 1, 2027 |
Study information
Verified date |
September 2023 |
Source |
Paracelsus Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare plain old balloon angioplasty with
sirolimus-coated balloon angioplasty in patients with an arteriovenous shunt stenosis. The
main question we aim to answer is, how patency is affected by each of the randomised
treatment modality.
Description:
This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular
Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the
two treatment options (plain old ballon angioplasty versus sirolimus coated balloon
angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2
years. Follow-up data will be collected to answer the endpoints and will include all
available follow-ups to monitor the shunt up to 2 years after the procedure. Typically,
follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months
after the procedure.
The shunts are checked for functionality as part of the dialysis required three times a week
and presented to our department beforehand in need. This saves chronically ill patients the
additional waiting time in hospital outpatient departments.