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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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date October 1, 2027
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age at least 18 years - Informed consent with signature - Maturated shunt, defined as already in use for two weeks - Shunt stenosis in need of intervention Exclusion Criteria - Pregnant or breastfeeding women - Active infection or sepsis - Incapacitated patients - Lesions in the affected stenosis already pretreated by stenting in the same area shunt. - Patients currently participating in another study - Central venous stenosis worthy of treatment - intolerance to sirolimus - coagulopathy - radiotherapy - patients on immunosuppressive therapy - use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).

Study Design


Intervention

Radiation:
Balloon Angioplasty
Revascularisation procedures will be performed according to randomised list.

Locations

Country Name City State
Austria University Hospital of Salzburg, Paracelsus Medical University Salzburg

Sponsors (2)

Lead Sponsor Collaborator
Paracelsus Medical University MedAlliance Swiss Medical Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Primary Lesion Target Patency of the arteriovenous shunt stenosis The incidence of patency will be analysed after reopening the stenosis of the arteriovenous shunt. 2 years
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