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Ultrasound-guided balloon angioplasty of venous av shunt stenosis compared to standard therapy under fluoroscopy

Ultrasound-guided balloon angioplasty of venous av shunt stenosis compared to standard therapy under fluoroscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015499
Enrollment
88
Registered
2018-09-11
Start date
2018-09-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N18.5 T82.5

Interventions

Group 1: ultrasound guided angioplasty of arteriovenous fistula stenosis Group 2: angioplasty of arteriovenous fistula stenosis under flouroscopy

Sponsors

Sana Klinikum Offenbach GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: Exclusion criteria: - lack of consent, - central venous stenosis (clinical and sonographic suspicion), - arterial stenosis, - occlusion, - infections in the shunt area

Design outcomes

Primary

MeasureTime frame
Improvement in shunt volume flow within 24 hours after angioplasty as measured by the difference in shunt volume flow post-intervention minus pre-intervention Main target: - Difference of shunt volume flow from post-intervention to pre-intervention

Secondary

MeasureTime frame
Secondary outcome variables: - Difference in shunt volume flow after 1 and 3 months compared to baseline (pre-intervention) - frequency of complications (bleeding, occlusion, change of procedure), - duration of the intervention, - Reintervention rate within 3 months

Countries

Germany

Contacts

Public ContactUdo Warkotsch

Sana Klinikum Offenbach GmbH

udo.warkotsch@sana.de0049 69 8405 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026