ltrasound-guided balloon angioplasty of venous av shunt stenosis compared to standard therapy under fluoroscopy
Not Applicable
Recruiting
- Conditions
- N18.5T82.5Chronic kidney disease, stage 5Mechanical complication of other cardiac and vascular devices and implants
- Registration Number
- DRKS00015499
- Lead Sponsor
- Sana Klinikum Offenbach GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- Hemodialysis patients with av shunt problems due to venous stenosis
- Patients in the preparation for hemodialysis with no av shunt maturation due to venous stenosis
- Consent for study participation and follow-up examinations
- Age of patients between 18 and 90 years
Exclusion Criteria
- lack of consent,
- central venous stenosis (clinical and sonographic suspicion),
- arterial stenosis,
- occlusion,
- infections in the shunt area
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in shunt volume flow within 24 hours after angioplasty as measured by the difference in shunt volume flow post-intervention minus pre-intervention<br>Main target:<br>- Difference of shunt volume flow from post-intervention to pre-intervention
- Secondary Outcome Measures
Name Time Method Secondary outcome variables:<br>- Difference in shunt volume flow after 1 and 3 months compared to baseline (pre-intervention)<br>- frequency of complications (bleeding, occlusion, change of procedure),<br>- duration of the intervention,<br>- Reintervention rate within 3 months